Clinical Trials List
Protocol NumberOBI-858-003
Active
2025-03-01 - 2027-08-31
Phase II
Recruiting5
ICD-10Z41.1
Encounter for cosmetic surgery
ICD-9V50.1
Elective surgery for other plastic surgery for unacceptable cosmetic appearance
A single-therapy, multicenter, repeated-dose phase 2 trial was conducted to evaluate the safety of OBI-858 in subjects with moderate to severe frown lines.
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Sponsor
OBIGEN PHARMA, INC.
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Trial scale
Taiwan Multiple Center
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Update
2026/08/26
Investigators and Locations
Co-Principal Investigator
- 鄭樁昱 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HSIAO-CHEN LEE 無
- 張兆瑋 無
- 陳威宇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ya-Ching Chang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Moderate to severe frown lines
Objectives
Primary Objective:
• To evaluate the safety of repeated OBI-858 injections
Secondary Objectives:
• To evaluate the efficacy of repeated OBI-858 injections
• To evaluate the immunogenicity of repeated OBI-858 injections
Test Drug
OBI-858
Active Ingredient
BOTULINUM TOXIN TYPE A
Dosage Form
Freeze-dried injection
Dosage
100U/vial
Endpoints
The number of adverse events, serious adverse events, or adverse events of particular concern experienced by subjects from day 1 to day 365, and the number of subjects with clinically significant abnormal laboratory test results.
Inclution Criteria
1. Age includes male and female adults aged 20 years and older.
2. As assessed by the investigating physician and the participant, the severity of frown lines when frowning is at least grade 2 (grade 0 is no frown lines, grade 1 is mild, grade 2 is moderate, and grade 3 is severe).
3. The participant voluntarily signs a participant consent form, and as assessed by the investigating physician or their authorized personnel, the participant's physical and mental condition is suitable for participating in this trial, and they are willing to comply with the trial procedures.
1. As assessed by the investigating physician, the severity of frown lines in a relaxed state is grade 2.
2. The participant has any medical conditions that may lead to a higher risk after receiving the investigational drug (e.g., diseases that affect neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, and motor neuron disease).
3. As assessed by the investigating physician, the participant has a clinically significant medical condition (e.g., cardiovascular, respiratory, or endocrine disorders).
4. As assessed by the investigating physician, the participant's laboratory test results show clinically significant abnormalities. If a subject's laboratory test results are outside the normal range, but are assessed by the investigating physician as clinically insignificant, the subject may participate in this trial with the physician's consent.
5. The subject has a history of facial nerve palsy or ptosis.
6. The subject has a skin disease or infection at the injection site.
7. The subject received botulinum toxin injections within six months prior to the screening period.
8. The subject is known to have a past history of botulism or idiopathic reactions to botulinum toxin.
9. The subject has previously received botulinum toxin vaccines for any serotype.
10. The subject is known to have an allergic or idiopathic reaction to the excipients or related components of the botulinum toxin product.
11. Subjects must not use any medications that may affect neuromuscular responses and the efficacy of the investigational drug within the four weeks prior to the screening period or during the trial, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterases (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
12. Subjects who, within the six months prior to the screening period, underwent a physician-assessed treatment with non-Botox products that may affect frown lines or forehead wrinkles, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency, ultrasound), facial resurfacing (e.g., laser, chemical peels), permanent implants, IPL treatments, or dermabrasion.
13. Subjects who have previously received a facelift, permanent implants, or have scars on their forehead or between their eyebrows that may affect treatment outcomes.
14. Subjects are known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
15. Subjects who are expected to undergo facial cosmetic procedures during the trial that may affect treatment outcomes, including but not limited to: hyaluronic acid injections, IPL treatments, deep chemical peels, or dermabrasion.
16. Subjects who are expected to receive treatment with any serum type of Botox product during the trial.
17. The subject is pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
18. The subject is fertile but does not wish to abstain from sexual intercourse for 6 months after receiving OBI-858 injection, or for the subject or their partner to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. A female subject will be considered infertile if any of the following conditions are met:
a. Physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone (FSH) concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months.
b. Six weeks after hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
19. The subject participated in other clinical trials within 28 days prior to receiving the investigational drug injection.
20. The participant was deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
2. As assessed by the investigating physician and the participant, the severity of frown lines when frowning is at least grade 2 (grade 0 is no frown lines, grade 1 is mild, grade 2 is moderate, and grade 3 is severe).
3. The participant voluntarily signs a participant consent form, and as assessed by the investigating physician or their authorized personnel, the participant's physical and mental condition is suitable for participating in this trial, and they are willing to comply with the trial procedures.
1. As assessed by the investigating physician, the severity of frown lines in a relaxed state is grade 2.
2. The participant has any medical conditions that may lead to a higher risk after receiving the investigational drug (e.g., diseases that affect neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, and motor neuron disease).
3. As assessed by the investigating physician, the participant has a clinically significant medical condition (e.g., cardiovascular, respiratory, or endocrine disorders).
4. As assessed by the investigating physician, the participant's laboratory test results show clinically significant abnormalities. If a subject's laboratory test results are outside the normal range, but are assessed by the investigating physician as clinically insignificant, the subject may participate in this trial with the physician's consent.
5. The subject has a history of facial nerve palsy or ptosis.
6. The subject has a skin disease or infection at the injection site.
7. The subject received botulinum toxin injections within six months prior to the screening period.
8. The subject is known to have a past history of botulism or idiopathic reactions to botulinum toxin.
9. The subject has previously received botulinum toxin vaccines for any serotype.
10. The subject is known to have an allergic or idiopathic reaction to the excipients or related components of the botulinum toxin product.
11. Subjects must not use any medications that may affect neuromuscular responses and the efficacy of the investigational drug within the four weeks prior to the screening period or during the trial, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterases (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
12. Subjects who, within the six months prior to the screening period, underwent a physician-assessed treatment with non-Botox products that may affect frown lines or forehead wrinkles, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency, ultrasound), facial resurfacing (e.g., laser, chemical peels), permanent implants, IPL treatments, or dermabrasion.
13. Subjects who have previously received a facelift, permanent implants, or have scars on their forehead or between their eyebrows that may affect treatment outcomes.
14. Subjects are known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
15. Subjects who are expected to undergo facial cosmetic procedures during the trial that may affect treatment outcomes, including but not limited to: hyaluronic acid injections, IPL treatments, deep chemical peels, or dermabrasion.
16. Subjects who are expected to receive treatment with any serum type of Botox product during the trial.
17. The subject is pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
18. The subject is fertile but does not wish to abstain from sexual intercourse for 6 months after receiving OBI-858 injection, or for the subject or their partner to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. A female subject will be considered infertile if any of the following conditions are met:
a. Physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone (FSH) concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months.
b. Six weeks after hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
19. The subject participated in other clinical trials within 28 days prior to receiving the investigational drug injection.
20. The participant was deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
Exclusion Criteria
1. The severity of frown lines in a relaxed state reaches grade 2, as assessed by the testing physician.
2. The subject has any medical condition that could potentially increase the risk after receiving the investigational drug (e.g., diseases affecting neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, motor neuron disease).
3. The subject has a clinically significant medical condition, as assessed by the testing physician (e.g., cardiovascular, respiratory, or endocrine disorders).
4. The subject's laboratory test results are clinically significant, as assessed by the testing physician. If a subject's laboratory test results are outside the normal range but are assessed by the testing physician as clinically insignificant, participation in this trial may be permitted with the testing physician's consent.
5. The subject has a history of facial nerve palsy or ptosis.
6. The subject has a skin disease or infection at the injection site.
7. The subject received botulinum toxin injections within six months prior to the screening period.
8. The subject is known to have a past history of botulism or idiopathic reactions to botulism.
9. The subject has previously received a botulinum toxin vaccine for any serotype.
10. The subject is known to have an allergic or idiopathic reaction to the excipients or related components of botulinum toxin products.
11. Subjects must not use any medications that may affect neuromuscular responses and the efficacy of the investigational drug within the four weeks prior to the screening period or during the trial, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterases (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
12. Subjects who, within the six months prior to the screening period, underwent a physician-assessed treatment with non-Botox products that may affect frown lines or forehead wrinkles, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency, ultrasound), facial resurfacing (e.g., laser, chemical peels), permanent implants, IPL treatments, or dermabrasion.
13. Subjects who have previously received a facelift, permanent implants, or have scars on their forehead or between their eyebrows that may affect treatment outcomes.
14. Subjects are known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
15. Subjects who are expected to undergo facial cosmetic procedures during the trial that may affect treatment outcomes, including but not limited to: hyaluronic acid injections, IPL treatments, deep chemical peels, or dermabrasion.
16. Subjects who are expected to receive treatment with any serum type of Botox product during the trial.
17. The subject is pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
18. The subject is fertile but does not wish to abstain from sexual intercourse for 6 months after receiving OBI-858 injection, or for the subject or their partner to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. A female subject will be considered infertile if any of the following conditions are met:
a. Physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone (FSH) concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months.
b. Six weeks after hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
19. The subject participated in other clinical trials within 28 days prior to receiving the investigational drug injection.
20. The participant was deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
2. The subject has any medical condition that could potentially increase the risk after receiving the investigational drug (e.g., diseases affecting neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, motor neuron disease).
3. The subject has a clinically significant medical condition, as assessed by the testing physician (e.g., cardiovascular, respiratory, or endocrine disorders).
4. The subject's laboratory test results are clinically significant, as assessed by the testing physician. If a subject's laboratory test results are outside the normal range but are assessed by the testing physician as clinically insignificant, participation in this trial may be permitted with the testing physician's consent.
5. The subject has a history of facial nerve palsy or ptosis.
6. The subject has a skin disease or infection at the injection site.
7. The subject received botulinum toxin injections within six months prior to the screening period.
8. The subject is known to have a past history of botulism or idiopathic reactions to botulism.
9. The subject has previously received a botulinum toxin vaccine for any serotype.
10. The subject is known to have an allergic or idiopathic reaction to the excipients or related components of botulinum toxin products.
11. Subjects must not use any medications that may affect neuromuscular responses and the efficacy of the investigational drug within the four weeks prior to the screening period or during the trial, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterases (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
12. Subjects who, within the six months prior to the screening period, underwent a physician-assessed treatment with non-Botox products that may affect frown lines or forehead wrinkles, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency, ultrasound), facial resurfacing (e.g., laser, chemical peels), permanent implants, IPL treatments, or dermabrasion.
13. Subjects who have previously received a facelift, permanent implants, or have scars on their forehead or between their eyebrows that may affect treatment outcomes.
14. Subjects are known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
15. Subjects who are expected to undergo facial cosmetic procedures during the trial that may affect treatment outcomes, including but not limited to: hyaluronic acid injections, IPL treatments, deep chemical peels, or dermabrasion.
16. Subjects who are expected to receive treatment with any serum type of Botox product during the trial.
17. The subject is pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
18. The subject is fertile but does not wish to abstain from sexual intercourse for 6 months after receiving OBI-858 injection, or for the subject or their partner to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. A female subject will be considered infertile if any of the following conditions are met:
a. Physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone (FSH) concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months.
b. Six weeks after hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
19. The subject participated in other clinical trials within 28 days prior to receiving the investigational drug injection.
20. The participant was deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
The Estimated Number of Participants
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Taiwan
200 participants
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Global
200 participants
