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Completed

NCT Number: NCT06827457

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults.

This study is designed to evaluate the safety, tolerability, PK and PD of GenSci120 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.

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Key information

Conditions

Autoimmune Disease Autoimmune Diseases Immune System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 20040, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female, between 18 and 55 years of age (inclusive) at the date of signed informed consent form (ICF), each cohort must include at least 3 participants of a single gender.
  • Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and total body weight ≥ 50 kg (Male) / ≥ 45 kg (Female) at screening.
  • No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, tumor biomarker, et al.), electrocardiogram (ECG) and pulmonary imaging tests, or value beyond normal reference range considered not clinically significant.
  • Ability to understand the trial procedures, volunteer to participate in the trial, and could provide written informed consent.

Exclusion criteria

  • Known allergy to any component in the GenSci120 formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.
  • The proposed injection site has tattoos, sunburn, scarring, or other factors that may interfere with the evaluation of the injection site.

(3) History of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, or other significant medical history that, in the investigator's opinion, may affect the assessment of this study.

（4）Severe infection, chronic infection, opportunistic infection, etc., within 3 months before screening, or systemic antimicrobial treatment for infections (including but not limited to viral, bacterial, fungal, parasitic infections) within 4 weeks prior to randomization.

（5）Use or intend to use any prescription medication to manage chronic/ongoing condition, and any acute medication use (including prescription medication, over-the-counter medication, or dietary supplements) within 14 days prior to administration.

（6)Participated in any clinical trials of investigational drugs (including investigational vaccines) and used investigational drugs within 3 months or within 5 terminal elimination half-lives (whichever is longer) prior to administration; participated in any clinical trials of medical devices within 3 months prior to screening (not including failed screening participants); currently participating in other clinical trials.

（7) Any other medical condition (at the investigator's discretion) that would impair the participant's ability to tolerate the IMP or proceed with the planned study procedures.

Treatment and study plan

GenSci120

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

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

    Time frame: 113 days

  2. Incidence and severity of serious adverse events (SAEs)

    Time frame: 113 days

  3. Clinically significant changes from baseline

    Time frame: 113 days

  4. Concentration of GenSci120 in plasma samples.

    Time frame: 113 days

  5. Pharmacokinetics-AUC0-last

    Time frame: 113 days

  6. Pharmacokinetics-AUC0-inf

    Time frame: 113 days

  7. Pharmacokinetics-Tmax

    Time frame: 113 days

  8. Pharmacokinetics-Cmax

    Time frame: 113 days

  9. Pharmacokinetics-CL/F

    Time frame: 113 days

  10. Pharmacokinetics-t1/2

    Time frame: 113 days

  11. flow cytometry

    Time frame: 113 days

  12. Incidence and the time of anti-drug antibody (ADA) positive and neutralizing antibody (NAb) positive (if applicable) after GenSci120 administration.

    Time frame: 113 days

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 GenSci120 in Healthy Adult Participants in China

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Dec 24, 2025

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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