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NCT Number: NCT07693738

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

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.

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Key information

Conditions

AD

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location status: Recruiting

Location contact

Jing Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSGJ-716

Drug

Single and multiple subcutaneous injection

Placebo

Drug

Single and multiple subcutaneous injection

Primary outcomes

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

    Time frame: 85 days

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: 85 days

  2. Time to maximum concentration (Tmax)

    Time frame: 85 days

  3. Elimination half-life (t1/2)

    Time frame: 85 days

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

    Time frame: 85 days

  5. Incidence of Anti-Drug Antibody (ADA)

    Time frame: 85 days

Study contacts

Contact information is provided by the study sponsor or research team.

Qinghong Zhou

CONTACT

[email protected]

+86 189113015

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of SSGJ-716 Injection Administered Subcutaneously in Healthy Chinese Adults and Participants With Moderate-to-Severe Atopic Dermatitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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