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Recruiting NCT07366866

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

Phase I Interventional Autoimmune Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenSci136, Placebo.
Who it may be relevant to
Registry conditions: Autoimmune Disease. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Drug GenSci136
    Administered SC.
  • Drug Placebo
    Administered SC.

Primary outcome measures

  • ● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs) [Time frame: Day1-Day113]
Secondary outcome measures (10)
  • Serum Concentration of free GenSci136/total GenSci136 [Time frame: Day1-Day113]
  • Maximum serum concentration (Cmax) [Time frame: Day1-Day113]
  • Time to maximum serum concentration (Tmax) [Time frame: Day1-Day113]
  • Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) [Time frame: Day1-Day113]
  • Area under concentration-time from time zero to infinity (AUC0-inf) [Time frame: Day1-Day113]
  • Terminal elimination half-life (t1/2) [Time frame: Day1-Day113]
  • Clearance (CL/F) [Time frame: Day1-Day113]
  • Apparent volume of distribution (Vd/F) [Time frame: 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. [Time frame: Day1-Day113]
  • Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration. [Time frame: Day1-Day113]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

China · 1 center
  • Huashan Hospital — Shanghai

Identifiers

NCT: NCT07366866 · GenSci136-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗