Health Adult SubjectsPhase 1NCT07650383
A Study to Evaluate ENERGI-F705 Tablets in Healthy Volunteers
A Phase 1 study testing ENERGI-F705 Tablets 60 mg and ENERGI-F705 Tablets 120 mg in people with Health Adult Subjects, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- ENERGI-F705 Tablets 60 mg and ENERGI-F705 Tablets 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2025to 19 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- -
Who cannot join
- 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.
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- 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)
- 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
- Having a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- The result of AST or ALT >2 times the upper limit of normal or presence of clinically significant abnormality, as judged by the Investigator.
- 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.
- Presence of, history of, or suspected gout, hyperuricemia or urolithiasis, as judged by the Investigator.
- Clinically significant ECG abnormality at screening.
- Presence of risk for QT prolongation, as judged by the Investigator.
- Regular smoker.
- Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening)
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Adult Subjects
- Being tested
- ENERGI-F705 Tablets 60 mg, ENERGI-F705 Tablets 120 mg, Vehicle Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGI-F705 Tablets 60 mgDrug
ENERGI-F705 tablets administered orally under fasting conditions.
ENERGI-F705 Tablets 120 mgDrug
ENERGI-F705 tablets administered orally under fasting conditions.
Vehicle ControlDrug
Matched vehicle control tablets administered orally under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| ENERGI-F705 60 mg | Active comparator | Not described Receives: Drug: ENERGI-F705 Tablets 60 mg |
| ENERGI-F705 120 mg | Active comparator | Not described Receives: Drug: ENERGI-F705 Tablets 120 mg |
| Vehicle Control | Placebo comparator | Not described Receives: Drug: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of subjects with treatment-emergent adverse events (TEAEs).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From pre-dose to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start24 Feb 2025
- Primary completion6 May 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650383
- Sponsor's protocol ID
- ENERGI-F705-01
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07650383
- Acronym / sponsor ID
- ENERGI-F705-01
- Conditions
- Health Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENERGI-F705 Tablets 60 mgENERGI-F705 tablets administered orally under fasting conditions. | Drug | ENERGI-F705 60 mg |
| ENERGI-F705 Tablets 120 mgENERGI-F705 tablets administered orally under fasting conditions. | Drug | ENERGI-F705 120 mg |
| Vehicle ControlMatched vehicle control tablets administered orally under fasting conditions. | Drug | Vehicle Control |
Primary outcome
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)
Time frame: From dosing through end of study (approximately 4 days post-dose)
Number and percentage of subjects with treatment-emergent adverse events (TEAEs).
8 secondary outcomes
Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From pre-dose to 72 hours post-dose
Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Time frame: From pre-dose to 72 hours post-dose
Apparent Total Body Clearance (CL/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Time frame: From pre-dose to 72 hours post-dose
Apparent Volume of Distribution (Vd/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Time frame: From pre-dose to 72 hours post-dose
Whole Blood Adenosine Triphosphate (ATP) Level Following Single Oral Administration of ENERGI-F705 Tablets
Time frame: From pre-dose to 72 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENERGI-F705 Tablets 60 mg and ENERGI-F705 Tablets 120 mg in people with Health Adult Subjects, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) (time frame: From dosing through end of study (approximately 4 days post-dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.