Evaluation of 626 in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects (HS)
• Intervention / Treatment: Drug: 626; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qinghong Zhou; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Shanghai, China, 200080
    • Recruiting
    • Shanghai General Hospital
    • Contact: Xueying Ding, PhD; Phone Number: +86 13761642319; Email: dingxueying@126.com
    • Contact: Xueying Ding, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 626 Group S1 for subcutaneous injection; dose level 1 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection
Experimental: 626 Group S2 for subcutaneous injection; dose level 2 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection
Experimental: 626 Group S3 for subcutaneous injection; dose level 3 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection
Experimental: 626 Group S4 for subcutaneous injection; dose level 4 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection
Experimental: 626 Group S5 for subcutaneous injection; dose level 5 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection
Experimental: 626 Group S6 for subcutaneous injection; dose level 6 of 626	Drug: 626; Single subcutaneous injection; Other Names: SSGJ-626; Drug: Placebo; Single subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak concentration (Cmax) will be calculated.	90 days
Tmax	Time to peak concentration (Tmax) will be calculated.	90 days
AUC0-last	Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated.	90 days
Incidence of Anti-Drug Antibody	Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive.	90 days

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SSGJ-626-HV-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No