Phase 1 Clinical Study of GenSci164 Injection

ConditionHealthy Adult Trial Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

This is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single subcutaneous injection in healthy adult participants in China.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female, aged between 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF).

Body weight ≥ 50 kg for males and ≥ 45 kg for females at screening, and body mass index (BMI) between 18 and 30 kg/m2 (inclusive).

No clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, etc.), electrocardiogram (ECG), and pulmonary imaging tests, or values outside the normal reference range considered not clinically significant by the investigator during the screening period or before randomization.

Men and women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures from the screening period to 3 months after the end of the study, and not plan to father a child (for men) or become pregnant (for women) from signing the ICF to 3 months after the end of the study. WOCBP must have a pregnancy test result within the normal range at screening or before randomization, and must not be breastfeeding. Women not of childbearing potential are those who are permanently sterilized (e.g., hysterectomy) or postmenopausal.

Disqualifiers

Known allergy to any component of the GenSci164 injection formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of allergic diathesis.

The proposed injection site has tattoos, sunburn, scarring, or other factors that might interfere with the evaluation of the injection site.

History or presence of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, psychiatric, neurological, respiratory, and/or other significant medical conditions that, in the investigator's opinion, may affect the evaluation of this study.

Known confirmed history of malignancy.

Trial design

Design model

Sequential

Treatments tested in this trial

GenSci164 Injection
Drug
6 dose cohorts
Placebo
Drug
6 dose cohorts

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: GenSci164 InjectionExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence and severity of adverse events (AEs) assessed by CTCAE v6.0

Adverse events (AEs)will be identified and collected from physical examination, vital signs, laboratory tests, 12-lead ECG, and other clinical assessments from Day 1 dosing up to 113 days post dose. Severity will be graded per NCI CTCAE v6.0. AEs will be summarized by number and percentage of affected participants, and further categorized by System Organ Class (SOC), Preferred Term (PT), and severity grade.

Time frame