RecruitingPhase 1NCT06674525

Evaluation of 626 in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

50 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Subjects (HS)

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

Able to understand protocol requirements and sign a written ICF.
Male or female subjects aged 18-45 years when signing the ICF.
Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m2.
Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.

Exclusion Criteria7

History of severe allergy, or with a history of allergy to the study treatment or related excipients.
With any clinically significant diseases prior to the screening visit.
Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
History of of significant alcohol abuse.
History of significant drug abuse.
Subjects who have positive result for urine nicotine test at screening.
Pregnant, or nursing females.