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New drug GenSci155 tested in healthy people for first time

NCT ID NCT07638800

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tests the safety and tolerability of a new drug called GenSci155 in 68 healthy adults aged 18-60. Participants receive either the drug or a placebo by IV injection, with doses increasing in later groups. The study does not aim to treat any disease, but to gather initial safety data before testing in patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GenSci155 injection

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

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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 60 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.Healthy adult male or female trial participants, aged between 18 and 60 years (inclusive) Male body weight ≥ 50 kg and female body weight ≥ 45 kg; body mass index (BMI) between 19 and 28 kg/m² (inclusive) at screening 3.In good general condition as determined by medical history, physical examination, vital signs, ECG, laboratory tests, infectious diseases screening and urine drug screening with no clinically significant abnormalities as judged by the investigator . 4.Female trial participants must have a negative pregnancy test results at screening and baseline. 5.Male and female trial participants of childbearing potential must agree to use non-pharmacological contraception from screening until 3 months after the last dose. From the time of signing the ICF until 3 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female trial participants must have had no unprotected sexual intercourse within 14 days prior to screening. 6.Trial participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner. Exclusion Criteria: 1. History of hypersensitivity to IGF-1 agents or their ingredients; or a history of allergic diathesis or a history of allergic diseases. 2. History or current presence of hypoglycemia, or recurrent hypoglycemic episodes. 3. Severe trauma or major surgical procedure within 12 months prior to screening that, in the investigator's judgment, may affect the safety of the trial participants or the interpretation of the study results, or planning to undergo any surgery during the trial period. 4. Blood loss or donation exceeding 400 mL within 3 months prior to screening. 5. Poor peripheral venous access; or physical condition intolerant to sampling. 6. Presence of significant active systemic or local infection within 4 weeks prior to screening. 7. Presence of tattoo, sunburn, scar or any other factors at screening that may interfere with the assessment of the injection site at the intended injection area. 8. History or current presence of any clinically significant, poorly controlled chronic disease, organ dysfunction, or malignancy that, in the investigator's judgment, may affect participant safety or study conduct. 9. Clinically significant abnormalities in chest x-ray \[P-A\] at screening. 10. A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (AntiTP ), or hepatitis B virus (HBV) infection 11. Females who are breastfeeding during the screening period. 12.12-Lead ECG at screening showing any of the following: QTcF interval \> 450 ms; or heart rate \> 100 beats per minute; or any other clinically significant abnormality as determined by the investigator. 13.Any of the following laboratory abnormalities at screening: * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \> upper limit of normal (ULN); * Total bilirubin \> ULN and considered clinically significant by the investigator. * Abnormal international normalized ratio (INR) or activated partial thromboplastin time (aPTT) judged to be clinically significant by the investigator. * Estimated glomerular filtration rate (eGFR) \< lower limit of normal; * Hematology results below the lower reference limit for any of the following and considered clinically significant by the investigator: hemoglobin, platelet count, white blood cell count, absolute lymphocyte count, or absolute neutrophil count. * Triglyceride or low-density lipoprotein cholesterol (LDL-C) levels above the upper reference limit and considered clinically significant by the investigator. 14.Use of any IGF-1 agents within 6 months or 5 half-lives (whichever is longer) prior to screening. 15.Use of any prescription drugs, over-the-counter medications (including but not limited to vitamins, herbal supplements, dietary supplements, and health products), traditional Chinese medicines, or Chinese patent medicines within 14 days or 5 half-lives (whichever is longer) prior to screening or planned use during the study period. 16.Participation in another clinical trial within 3 months or 5 half-lives (whichever is longer) prior to screening (except for trial participants who received no intervention), or current participation in any other clinical trial. 17.Average daily cigarette consumption of ≥ 5 cigarettes within 6 months prior to screening; or unable to refrain from smoking for the duration of the study; or a positive urine cotinine test. 18.Weekly intake of alcohol exceeding the criteria \[defined as \>14 units of alcohol on average per week (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of spirits)\] within 6 months prior to screening, or inability to stop drinking during the study, or a positive alcohol test. 19.Positive urine drug screen for substances including, but not limited to: morphine, ketamine, methylenedioxymethamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine. 20.History of drug abuse; or use of so-called "soft" drugs within 3 months prior to screening; or use of so-called "hard" drugs within 1 year prior to screening. 21.Any other condition that, in the judgment of the investigator, would make the trial participant unsuitable for participation in this clinical trial.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070, China

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