Clinical trial NCT06827457: A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults.
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 GenSci120 in Healthy Adult Participants in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autoimmune Disease
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: 113 days
measure: Incidence and severity of serious adverse events (SAEs)
timeFrame: 113 days
measure: Clinically significant changes from baseline
timeFrame: 113 days
measure: Concentration of GenSci120 in plasma samples.
timeFrame: 113 days
measure: Pharmacokinetics-AUC0-last
timeFrame: 113 days
measure: Pharmacokinetics-AUC0-inf
timeFrame: 113 days
measure: Pharmacokinetics-Tmax
timeFrame: 113 days
measure: Pharmacokinetics-Cmax
timeFrame: 113 days
measure: Pharmacokinetics-CL/F
timeFrame: 113 days
measure: Pharmacokinetics-t1/2
timeFrame: 113 days
measure: flow cytometry
timeFrame: 113 days
measure: Incidence and the time of anti-drug antibody (ADA) positive and neutralizing antibody (NAb) positive (if applicable) after GenSci120 administration.
timeFrame: 113 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: