A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSGJ-716, Placebo.
- Who it may be relevant to
- Registry conditions: AD. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug SSGJ-716
Single and multiple subcutaneous injection - Drug Placebo
Single and multiple subcutaneous injection
Primary outcome measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: 85 days]
Secondary outcome measures (5)
- Maximum observed concentration (Cmax) [Time frame: 85 days]
- Time to maximum concentration (Tmax) [Time frame: 85 days]
- Elimination half-life (t1/2) [Time frame: 85 days]
- Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) [Time frame: 85 days]
- Incidence of Anti-Drug Antibody (ADA) [Time frame: 85 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT07693738 · SSGJ-716-HV/AD-I-01