Evaluation of 627 in Healthy Adult Subjects

Not Applicable

Not yet recruiting

• Conditions: Healthy Subjects (HS)
• Interventions: Biological: 627; Other: Placebo

• Registration Number: NCT07065136
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-627 in healthy adult subjects after single subcutaneous injection.

Detailed Description

Seven dose groups are planned for dose escalation in SAD of this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S7 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-20
• Primary Completion: 2026-09-18
• Study Completion: 2026-09-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• 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 Criteria

• History of severe allergy, or with a history of allergy to the study treatment or related excipients.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
627	627	-
627	Placebo	-
Placebo	627	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	D99	Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.