New drug ENERGI-F705 takes first step: safety check in 24 volunteers
NCT ID NCT07650383
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested the safety and tolerability of a single dose of ENERGI-F705 tablets in 24 healthy adults aged 18 to 44. Participants were randomly assigned to receive either a 60 mg or 120 mg dose of the drug or a placebo (vehicle control). The study measured side effects and how the drug moves through the body, but it was not designed to test any treatment effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ENERGI-F705 tablets
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. \- 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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Taipei Medical University Hospital
Taipei, Taiwan
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