Evaluation of 626 in Healthy Adult Subjects

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: 626; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06674525

SSGJ-626-HV-I-01

Details and patient eligibility

About

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.

Full description

Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 6 patient groups

626 Group S1 for subcutaneous injection

Experimental group

Description:

dose level 1 of 626

Treatment:

Drug: Placebo

Drug: 626

626 Group S2 for subcutaneous injection

Experimental group

Description:

dose level 2 of 626

Treatment:

Drug: Placebo

Drug: 626

626 Group S3 for subcutaneous injection

Experimental group

Description:

dose level 3 of 626

Treatment:

Drug: Placebo

Drug: 626

626 Group S4 for subcutaneous injection

Experimental group

Description:

dose level 4 of 626

Treatment:

Drug: Placebo

Drug: 626

626 Group S5 for subcutaneous injection

Experimental group

Description:

dose level 5 of 626

Treatment:

Drug: Placebo

Drug: 626

626 Group S6 for subcutaneous injection

Experimental group

Description:

dose level 6 of 626

Treatment:

Drug: Placebo

Drug: 626