Evaluating the safety and tolerability of GenSci120 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 GenSci120 in Healthy Adult Participants in China

This study is testing a new drug called GenSci120 in healthy adults to see if it is safe and how it affects their bodies compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06827457 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GenSci120 through a randomized, double-blind, placebo-controlled design involving healthy adult participants. The trial will include both a treatment group receiving GenSci120 and a control group receiving a placebo. Participants will be monitored for any adverse effects and changes in health parameters throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18 and 30 kg/m2.

Not a fit: Patients with known allergies to any components of GenSci120 or a history of severe allergic reactions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of GenSci120's safety profile, paving the way for its use in treating autoimmune diseases.

How similar studies have performed: While this specific approach is novel, similar studies evaluating the safety and tolerability of new treatments in healthy adults have shown success in the past.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and total body weight ≥ 50 kg (Male) / ≥ 45 kg (Female) at screening.
3. 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.
4. Ability to understand the trial procedures, volunteer to participate in the trial, and could provide written informed consent.

Exclusion Criteria:

1. 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.
2. 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.

Where this trial is running

Shanghai, Shanghai

• Huashan Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jingsi Li

Conditions Autoimmune Disease