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Healthy Adult Trial ParticipantsPhase 1NCT07638800

Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults

A Phase 1 study testing GenSci155 Injection in people with Healthy Adult Trial Participants, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Trial Participants
What is being tested?
GenSci155 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteChina
Study dates
28 Jul 2026to 28 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • History of hypersensitivity to IGF-1 agents or their ingredients; or a history of allergic diathesis or a history of allergic diseases.
  • History or current presence of hypoglycemia, or recurrent hypoglycemic episodes.
  • 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.
  • Blood loss or donation exceeding 400 mL within 3 months prior to screening.
  • Poor peripheral venous access; or physical condition intolerant to sampling.
  • Presence of significant active systemic or local infection within 4 weeks prior to screening.
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  • 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.
  • 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.
  • Clinically significant abnormalities in chest x-ray [P-A] at screening.
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qingjiang Ni contact

+86 17712631723

niqingjiang@genscigroup.com

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Doses Study of GenSci155 Injection Administered Intravenously in Healthy Adult Trial Participants

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult trial participants.

Being tested
GenSci155 Injection, Placebo
Keywords
Healthy Volunteers, GenSci155

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenSci155 InjectionDrug

    Part 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts

  • PlaceboDrug

    Part 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts

Study groups in NCT07638800
Study groupRoleWhat they receive
GenSci155 InjectionExperimentalNot described
Receives: Drug: GenSci155 Injection
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part1：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures

    Measured: From dosing on Day 1 up to 22 days post dose

  2. Part2：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures

    Measured: From dosing on Day 1 up to 31 days post dose

Secondary outcomes (16)

  1. Part1:Area under the concentration-time curve (AUC0-t, AUC0-∞,AUC0-τ)of GenSci155

    Measured: From dosing on Day 1 up to 22 days post dose

  2. Part1:maximum concentration (Cmax)

    Measured: From dosing on Day 1 up to 22 days post dose

  3. Part1:time to maximum concentration (Tmax)

    Measured: From dosing on Day 1 up to 22 days post dose

  4. Part1:terminal elimination half-life (t1/2)

    Measured: From dosing on Day 1 up to 22 days post dose

  5. Part1:clearance (CL)

    Measured: From dosing on Day 1 up to 22 days post dose

  6. Part1:apparent volume of distribution (Vd)

    Measured: From dosing on Day 1 up to 22 days post dose

  7. Part2:maximum concentration at steady state (Cmax, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  8. Part2:minimum concentration at steady state (Cmin, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  9. Part2:time to maximum concentration at steady state (Tmax, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  10. Part2:average concentration at steady state (Cav, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  11. Part2:area under the concentration-time curve within a dosing interval at steady state (AUC0-τ, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  12. Part2:apparent volume of distribution at steady state(Vss)

    Measured: From dosing on Day 1 up to 31 days post dose

  13. Part2:clearance at steady state (CLss)

    Measured: From dosing on Day 1 up to 31 days post dose

  14. Part2: t1/2 at steady state (t1/2, ss)

    Measured: From dosing on Day 1 up to 31 days post dose

  15. Part2: accumulation factor (Rac)

    Measured: From dosing on Day 1 up to 31 days post dose

  16. Incidence rate, titer, and onset time of positive anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)

    Measured: From dosing on Day 1 up to 22 or 31 days post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start28 Jul 2026 (estimated)
  3. Primary completion16 Apr 2027 (estimated)
  4. Study completion28 Jul 2027 (estimated)

Resources

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638800
Sponsor's protocol ID
GenSci155-101
Status last verified
May 2026
First submitted
4 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GenSci155 Injection in people with Healthy Adult Trial Participants, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

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 4 inclusion and 26 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: opening soon, as of the sponsor's last update on 10 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qingjiang Ni (+86 17712631723, niqingjiang@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part1：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures (time frame: From dosing on Day 1 up to 22 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638800.

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 10 Jun 2026.

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