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NCT Number: NCT07366866

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.

This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
  • Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
  • Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening/baseline period and are not breastfeeding.
  • Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.

Exclusion criteria

  • Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.
  • Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
  • A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and/or other major disease that, in the opinion of the investigator, would affect the evaluation of the study.
  • Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.
  • Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening [including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine].
  • Participants judged by the investigator to be ineligible for other reasons.

Treatment and study plan

GenSci136

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. ● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)

    Time frame: Day1-Day113

Secondary outcomes

  1. Serum Concentration of free GenSci136/total GenSci136

    Time frame: Day1-Day113

    Serum concentrations at different time points will be listed and summarized by descriptive statistics.

  2. Maximum serum concentration (Cmax)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  3. Time to maximum serum concentration (Tmax)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  4. Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  5. Area under concentration-time from time zero to infinity (AUC0-inf)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  6. Terminal elimination half-life (t1/2)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  7. Clearance (CL/F)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  8. Apparent volume of distribution (Vd/F)

    Time frame: Day1-Day113

    PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.

  9. ● Changes from baseline in free and total a proliferation inducing ligand (APRIL) levels; ● Changes from baseline in free and total B-cell activating factor (BAFF) levels.

    Time frame: Day1-Day113

  10. Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration.

    Time frame: Day1-Day113

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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