Clinical Trials List
Protocol NumberENERGI-F705-01
Completed
2024-11-01 - 2025-11-15
Phase I
Recruiting1
ICD-10G20
Parkinson's disease
ICD-10G21.4
Vascular parkinsonism
ICD-9332.0
Paralysis agitans
A Phase I, Double-Blinded, Randomized, Vehicle-Controlled, and Single-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ENERGI-F705 Tablets in Healthy Volunteers
-
Trial Applicant
MITHRA BIOTECHNOLOGY INC.
-
Sponsor
Energenesis Biomedical
-
Trial scale
Taiwan Single Center
-
Update
2026/02/01
Investigators and Locations
Principal Investigator
MING-CHE LIU
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Healthy Volunteers
Objectives
To evaluate the safety of
ENERGI-F705 Tablets in
healthy subjects.
Test Drug
tablet
Active Ingredient
ADENINE
Dosage Form
110
Dosage
60MG
Endpoints
Number and percentage of subjects with Treatment
Emergent Adverse Events (TEAEs) from dosing to
the end of study (EOS).
Emergent Adverse Events (TEAEs) from dosing to
the end of study (EOS).
Inclution Criteria
1. All genders aged ≧18 to < 45 years.
2. Able to understand and sign informed consent form.
3. Able to communicate well with the Investigator and comply with the
requirements of the study.
4. Body mass index (BMI) ranged 18.5≦ BMI < 27 kg/m2.
5. Males weighting ≧50 kg and females weighting ≧45 kg.
6. Healthy subjects as determined by a responsible physician, based on
medical evaluation including medical history, physical examination,
concomitant medication, vital signs, 12-lead ECG, chest X-ray, and clinical
laboratory evaluations.
7. Is willing to follow the study life style instruction and protocol procedure.
2. Able to understand and sign informed consent form.
3. Able to communicate well with the Investigator and comply with the
requirements of the study.
4. Body mass index (BMI) ranged 18.5≦ BMI < 27 kg/m2.
5. Males weighting ≧50 kg and females weighting ≧45 kg.
6. Healthy subjects as determined by a responsible physician, based on
medical evaluation including medical history, physical examination,
concomitant medication, vital signs, 12-lead ECG, chest X-ray, and clinical
laboratory evaluations.
7. Is willing to follow the study life style instruction and protocol procedure.
Exclusion Criteria
1. History of adverse reactions or allergy of active ingredient, components in
investigational product (IP) or related products.
2. Significant drug abuse.
3. Having any medical history as judged by the Investigator (including but not
limited to neurological, psychiatric, endocrine, cardiovascular, respiratory,
gastrointestinal, hepatic, or renal disorders).
4. Presence of significant neurological, psychiatric, endocrine, cardiovascular,
respiratory, gastrointestinal, hepatic, renal, or other pathology, as judged by
the Investigator.
5. Pregnant or lactating women.
6. Having an acute illness or surgery within 4 weeks prior to dosing.
7. Other conditions not suitable for participating in this study as judged by the
Investigator.
8. History of cancer (malignancy) or have ever received any anti-cancer
therapy.
9. Taking any prescription, vaccine, herbal products or over-the-counter
(OTC) medication, including antacids, calcium, other supplements and
vitamins, that may interfere with the safety or PK/PD assessment judged by
the Investigator within 14 days prior to dosing.
10. Joining any drug clinical trial within 2 months prior to dosing.
11. Blood loss/donation of ≧250 mL within 2 months or blood loss/donation
of ≧500 mL within 3 months prior to dosing.
12. Healthy adult subjects or subjects’ active sexual partners disagree to use at
least one form of highly effective contraceptive methods during the study
period and for 5 half-lives of active ingredient plus 90 days (94 days in
total) after dosing. During this time, sperm or egg donation is prohibited
while contraceptive methods are in use.
investigational product (IP) or related products.
2. Significant drug abuse.
3. Having any medical history as judged by the Investigator (including but not
limited to neurological, psychiatric, endocrine, cardiovascular, respiratory,
gastrointestinal, hepatic, or renal disorders).
4. Presence of significant neurological, psychiatric, endocrine, cardiovascular,
respiratory, gastrointestinal, hepatic, renal, or other pathology, as judged by
the Investigator.
5. Pregnant or lactating women.
6. Having an acute illness or surgery within 4 weeks prior to dosing.
7. Other conditions not suitable for participating in this study as judged by the
Investigator.
8. History of cancer (malignancy) or have ever received any anti-cancer
therapy.
9. Taking any prescription, vaccine, herbal products or over-the-counter
(OTC) medication, including antacids, calcium, other supplements and
vitamins, that may interfere with the safety or PK/PD assessment judged by
the Investigator within 14 days prior to dosing.
10. Joining any drug clinical trial within 2 months prior to dosing.
11. Blood loss/donation of ≧250 mL within 2 months or blood loss/donation
of ≧500 mL within 3 months prior to dosing.
12. Healthy adult subjects or subjects’ active sexual partners disagree to use at
least one form of highly effective contraceptive methods during the study
period and for 5 half-lives of active ingredient plus 90 days (94 days in
total) after dosing. During this time, sperm or egg donation is prohibited
while contraceptive methods are in use.
The Estimated Number of Participants
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Taiwan
60 participants
-
Global
60 participants