A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis

NCT07693738 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SSGJ-716-HV/AD-I-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD). The study has two parts. The first part (Single Ascending Dose, SAD) will enroll healthy adults.The second part (Multiple Ascending Dose, MAD) will enroll participants with moderate-to-severe AD.

Conditions

AD

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  85 days

Secondary Outcomes (5)

• Maximum observed concentration (Cmax)

  85 days

• Time to maximum concentration (Tmax)

  85 days

• Elimination half-life (t1/2)

  85 days

• Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last)

  85 days

• Incidence of Anti-Drug Antibody (ADA)

  85 days

Study Arms (2)

SSGJ-716

EXPERIMENTAL

Drug: SSGJ-716

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SSGJ-716 DRUG

Single and multiple subcutaneous injection

SSGJ-716

Placebo DRUG

Single and multiple subcutaneous injection

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.
• 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)

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

Central Study Contacts

Qinghong Zhou

CONTACT

+86 189113015; 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 24, 2026
• First Posted: July 9, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): January 29, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)