A Study to Evaluate ENERGI-F705 Tablets in Healthy Volunteers

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

To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Health Adult Subjects
• Intervention / Treatment: Drug: ENERGI-F705 Tablets 60 mg; Drug: ENERGI-F705 Tablets 120 mg; Drug: Vehicle Control

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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

8. Negative test for human immunodeficiency virus (HIV), syphilis, hepatitis B virus surface antigen (HBsAg), and anti-HCV antibody at screening.

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Exclusion Criteria:

1. History of adverse reactions or allergy of active ingredient, components in 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.

    • Acceptable forms of highly effective contraceptive methods for female subjects include:

      • Surgically sterile (documented hysterectomy, documented bilateral salpingectomy, bilateral oophorectomy)
      • Placement of an intrauterine device (IUD) in conjunction with a barrier method (use of condom by the male partner)
      • Total sexual abstinence

    • Acceptable forms of highly effective contraceptive methods for male subjects include:

      • Surgically sterile (vasectomy with documented negative semen analysis)
      • Condom in conjunction with an IUD (used by the female partner)
      • Condom in conjunction with oral/implantable/injectable contraceptives (used by the female partner)
      • Total sexual abstinence
13. Having a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
14. The result of AST or ALT >2 times the upper limit of normal or presence of clinically significant abnormality, as judged by the Investigator.
15. The result of creatinine is abnormal or eGFR < 90 mL/min/1.73 m2 or presence of clinically significant abnormality, as judged by the Investigator.
16. Presence of, history of, or suspected gout, hyperuricemia or urolithiasis, as judged by the Investigator.
17. Clinically significant ECG abnormality at screening.
18. Presence of risk for QT prolongation, as judged by the Investigator.

19. Regular smoker.

    • Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening)

20. Consumed greater than 3 units of alcoholic beverages per day in average for the past 4 weeks prior to dosing.

    • One unit is equivalent to one can of beer (<10% alcohol; about 330 mL), one glass of wine (10~20% alcohol; about 150 mL), or one shot of distilled spirits (>20% alcohol; about 45 mL)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Control	Drug: Vehicle Control; Matched vehicle control tablets administered orally under fasting conditions.
Active Comparator: ENERGI-F705 60 mg	Drug: ENERGI-F705 Tablets 60 mg; ENERGI-F705 tablets administered orally under fasting conditions.
Active Comparator: ENERGI-F705 120 mg	Drug: ENERGI-F705 Tablets 120 mg; ENERGI-F705 tablets administered orally under fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)	Number and percentage of subjects with treatment-emergent adverse events (TEAEs).	From dosing through end of study (approximately 4 days post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	Cmax is defined as the highest observed whole blood concentration within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL.	From pre-dose to 72 hours post-dose
Time to Maximum Observed Whole Blood Concentration (Tmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	Tmax is defined as the time point at which Cmax is observed within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in hours.	From pre-dose to 72 hours post-dose
Trough Whole Blood Concentration (Ctrough) of ENERGI-F705 and Its Metabolite at 72 Hours Following Single Oral Administration	Ctrough is defined as the whole blood concentration measured at 72 hours post-dose. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL.	From pre-dose to 72 hours post-dose
Area Under the Whole Blood Concentration-Time Curve (AUC) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	AUC0-t is defined as the area under the concentration-time curve from time zero to the last measurable concentration time point. AUC0-∞ is defined as the area under the concentration-time curve from time zero to infinity. Both values will be reported separately for ENERGI-F705 and its metabolite in ng·h/mL.	From pre-dose to 72 hours post-dose
Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	T½ is defined as the terminal half-life, calculated as ln(2) / K_el ≈ 0.693 / K_el. Values will be reported separately for ENERGI-F705 and its metabolite in hours.	From pre-dose to 72 hours post-dose
Apparent Total Body Clearance (CL/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	CL/F is defined as the apparent total body clearance, calculated as Dose / AUC0-∞. Values will be reported separately for ENERGI-F705 and its metabolite in L/h.	From pre-dose to 72 hours post-dose
Apparent Volume of Distribution (Vd/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration	Vd/F is defined as the apparent volume of distribution, calculated as Dose / (K_el × AUC0-∞). Values will be reported separately for ENERGI-F705 and its metabolite in liters (L).	From pre-dose to 72 hours post-dose
Whole Blood Adenosine Triphosphate (ATP) Level Following Single Oral Administration of ENERGI-F705 Tablets	ATP levels will be measured in whole blood at each scheduled time point within the 72-hour sampling period.	From pre-dose to 72 hours post-dose

Collaborators and Investigators

• Sponsor: Energenesis Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): May 6, 2025
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ENERGI-F705-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No