Evaluation of 627 in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2026-09-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subjects (HS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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627

Group Type EXPERIMENTAL

627

Intervention Type BIOLOGICAL

subcutaneous injection

Placebo

Intervention Type OTHER

Single subcutaneous injection

Placebo

Group Type PLACEBO_COMPARATOR

627

Intervention Type BIOLOGICAL

subcutaneous injection

Placebo

Intervention Type OTHER

Single subcutaneous injection

Interventions

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627

subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Single subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes