Evaluation of 627 in Healthy Adult Subjects

NCT07065136 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: SSGJ-627-HV-01
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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.

  D99

Study Arms (2)

627

EXPERIMENTAL

Biological: 627; Other: Placebo

Placebo

PLACEBO COMPARATOR

Biological: 627; Other: Placebo

Interventions

627 BIOLOGICAL

subcutaneous injection

627; Placebo

Placebo OTHER

Single subcutaneous injection

627; Placebo

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.
• 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

Central Study Contacts

zhou

CONTACT

021-8029 7777; 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: April 22, 2025
• First Posted: July 15, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-04