Evaluation of 627 in Healthy Adult Subjects

Phase 1Not Yet RecruitingNCT07065136

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.108 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Healthy Subjects (HS)

Interventions

627BIOLOGICAL

subcutaneous injection

PlaceboOTHER

Single subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of participants with Adverse Events

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.

Time frame: D99

Central Contacts

zhou

CONTACT

021-8029 7777 zhouqinghong@3sbio.com

Data from ClinicalTrials.gov

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