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

NCT06827457 | Completed Phase 1

• 1 other identifier: GenSci120-101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Disease

Outcome Measures

Primary Outcomes (12)

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

  113 days

• Incidence and severity of serious adverse events (SAEs)

  113 days

• Clinically significant changes from baseline

  113 days

• Concentration of GenSci120 in plasma samples.

  113 days

• Pharmacokinetics-AUC0-last

  113 days

• Pharmacokinetics-AUC0-inf

  113 days

• Pharmacokinetics-Tmax

  113 days

• Pharmacokinetics-Cmax

  113 days

• Pharmacokinetics-CL/F

  113 days

• Pharmacokinetics-t1/2

  113 days

• flow cytometry

  113 days

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

  113 days

Study Arms (2)

GenSci120

EXPERIMENTAL

Single ascending doses of GenSci120 administered subcutaneously (SC).

Drug: GenSci120

Placebo

PLACEBO COMPARATOR

Administered SC.

Drug: Placebo

Interventions

GenSci120 DRUG

Administered SC.

GenSci120

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 20040, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 14, 2025
• Study Start: February 20, 2025
• Primary Completion: November 27, 2025
• Study Completion: December 16, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-08

Locations

CN (1)