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New drug ENERGI-F705 takes first step: safety check in 24 volunteers

NCT ID NCT07650383

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Feb 2025

Finished

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Taipei Medical University Hospital

    Taipei, Taiwan

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