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Evaluation of 626 in Healthy Adult Subjects

NCT ID: NCT06674525

Last Updated: 2024-12-10

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

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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626 Group S1 for subcutaneous injection

dose level 1 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

626 Group S2 for subcutaneous injection

dose level 2 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

626 Group S3 for subcutaneous injection

dose level 3 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

626 Group S4 for subcutaneous injection

dose level 4 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

626 Group S5 for subcutaneous injection

dose level 5 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

626 Group S6 for subcutaneous injection

dose level 6 of 626

Group Type EXPERIMENTAL

626

Intervention Type DRUG

Single subcutaneous injection

Placebo

Intervention Type DRUG

Single subcutaneous injection

Interventions

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626

Single subcutaneous injection

Intervention Type DRUG

Placebo

Single subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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SSGJ-626

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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai General Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qinghong Zhou

Role: CONTACT

Phone: +86 18911301578

Email: [email protected]

Facility Contacts

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Xueying Ding, PhD

Role: primary

Xueying Ding, PhD

Role: backup

Other Identifiers

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SSGJ-626-HV-I-01

Identifier Type: -

Identifier Source: org_study_id