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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).

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.

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.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    60 participants