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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Disease
• Intervention / Treatment: Drug: Placebo; Drug: GenSci136

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jingsi Li; Phone Number: +86 18301941524; Email: lijingsi@genscigroup.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital
      • Contact: Jing Zhang, Doctor; Phone Number: 021-52887926; Email: Zhangj_fudan@163.com
      • Contact: Xiaojie Wu, Doctor; Phone Number: +86 13524686330; Email: maomao_xj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
2. Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
3. 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.
4. 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:

1. 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.
2. Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
3. 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.
4. 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.
5. 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].
6. Participants judged by the investigator to be ineligible for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Administered SC.	Drug: Placebo; Administered SC.
Experimental: GenSci136; Single ascending doses of GenSci136 administered subcutaneously (SC).	Drug: GenSci136; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)	Day1-Day113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentration of free GenSci136/total GenSci136	Serum concentrations at different time points will be listed and summarized by descriptive statistics.	Day1-Day113
Maximum serum concentration (Cmax)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Time to maximum serum concentration (Tmax)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Area under concentration-time from time zero to infinity (AUC0-inf)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Terminal elimination half-life (t1/2)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Clearance (CL/F)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
Apparent volume of distribution (Vd/F)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.	Day1-Day113
● 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.		Day1-Day113
Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration.		Day1-Day113

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): February 7, 2027
• Study Completion (Estimated): March 9, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: GenSci136-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No