Evaluation of 626 in Healthy Adult Subjects

NCT06674525 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SSGJ-626-HV-I-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects (HS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cmax

  90 days

• Tmax

  90 days

• AUC0-last

  90 days

• Incidence of Anti-Drug Antibody

  90 days

Study Arms (6)

626 Group S1 for subcutaneous injection

EXPERIMENTAL

dose level 1 of 626

Drug: 626; Drug: Placebo

626 Group S2 for subcutaneous injection

EXPERIMENTAL

dose level 2 of 626

Drug: 626; Drug: Placebo

626 Group S3 for subcutaneous injection

EXPERIMENTAL

dose level 3 of 626

Drug: 626; Drug: Placebo

626 Group S4 for subcutaneous injection

EXPERIMENTAL

dose level 4 of 626

Drug: 626; Drug: Placebo

626 Group S5 for subcutaneous injection

EXPERIMENTAL

dose level 5 of 626

Drug: 626; Drug: Placebo

626 Group S6 for subcutaneous injection

EXPERIMENTAL

dose level 6 of 626

Drug: 626; Drug: Placebo

Interventions

626 DRUG

Single subcutaneous injection

Also known as: SSGJ-626

626 Group S1 for subcutaneous injection; 626 Group S2 for subcutaneous injection; 626 Group S3 for subcutaneous injection; 626 Group S4 for subcutaneous injection; 626 Group S5 for subcutaneous injection; 626 Group S6 for subcutaneous injection

Placebo DRUG

Single subcutaneous injection

626 Group S1 for subcutaneous injection; 626 Group S2 for subcutaneous injection; 626 Group S3 for subcutaneous injection; 626 Group S4 for subcutaneous injection; 626 Group S5 for subcutaneous injection; 626 Group S6 for subcutaneous injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, 200080, China

RECRUITING

Central Study Contacts

Qinghong Zhou

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 5, 2024
• Study Start: December 2, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)