A Study to Evaluate ENERGI-F705 Tablets in Healthy Volunteers

NCT07650383 | Completed Phase 1

• 1 other identifier: ENERGI-F705-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health Adult Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration

  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

  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

  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

  From pre-dose to 72 hours post-dose

• Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration

  From pre-dose to 72 hours post-dose

Study Arms (3)

ENERGI-F705 60 mg

ACTIVE COMPARATOR

Drug: ENERGI-F705 Tablets 60 mg

ENERGI-F705 120 mg

ACTIVE COMPARATOR

Drug: ENERGI-F705 Tablets 120 mg

Vehicle Control

PLACEBO COMPARATOR

Drug: Vehicle Control

Interventions

ENERGI-F705 Tablets 60 mg DRUG

ENERGI-F705 tablets administered orally under fasting conditions.

ENERGI-F705 60 mg

ENERGI-F705 Tablets 120 mg DRUG

ENERGI-F705 tablets administered orally under fasting conditions.

ENERGI-F705 120 mg

Vehicle Control DRUG

Matched vehicle control tablets administered orally under fasting conditions.

Vehicle Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All genders aged ≧18 to \< 45 years.
• Able to understand and sign informed consent form.
• Able to communicate well with the Investigator and comply with the requirements of the study.
• Body mass index (BMI) ranged 18.5≦BMI \< 27 kg/m2 .
• Males weighting ≧50 kg and females weighting ≧45 kg.
• 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.
• Is willing to follow the study life style instruction and protocol procedure
• Negative test for human immunodeficiency virus (HIV), syphilis, hepatitis B virus surface antigen (HBsAg), and anti-HCV antibody at screening.

You may not qualify if:

• History of adverse reactions or allergy of active ingredient, components in IP or related products.
• Significant drug abuse.
• Having any medical history as judged by the Investigator (including but not limited to neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorders).
• Presence of significant neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, renal, or other pathology, as judged by the Investigator.
• Pregnant or lactating women.
• Having an acute illness or surgery within 4 weeks prior to dosing.
• Other conditions not suitable for participating in this study as judged by the Investigator.
• History of cancer (malignancy) or have ever received any anti-cancer therapy.
• 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.
• Joining any drug clinical trial within 2 months prior to dosing.
• Blood loss/donation of ≧250 mL within 2 months or blood loss/donation of ≧500 mL within 3 months prior to dosing.
• 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)

Sponsors & Collaborators

• Energenesis Biomedical Co., Ltd.: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 16, 2026
• Study Start: February 24, 2025
• Primary Completion: May 6, 2025
• Study Completion: November 19, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

TW (1)