Evaluation of 627 in Healthy Adult Subjects

Sunshine Guojian Pharmaceutical

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy Subjects (HS)

Treatments

Other: Placebo

Biological: 627

Study type

Interventional

Funder types

Industry

Identifiers

NCT07065136

SSGJ-627-HV-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 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.
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.