ADPhase 1NCT07693738
A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing SSGJ-716 in people with AD, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- AD
- What is being tested?
- SSGJ-716
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 29 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Jing Zhang
About this study
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
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
- Being tested
- SSGJ-716, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-716Drug
Single and multiple subcutaneous injection
PlaceboDrug
Single and multiple subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-716 | Experimental | Not described Receives: Drug: SSGJ-716 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: 85 days
Secondary outcomes (5)
Maximum observed concentration (Cmax)
Measured: 85 days
Time to maximum concentration (Tmax)
Measured: 85 days
Elimination half-life (t1/2)
Measured: 85 days
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last)
Measured: 85 days
Incidence of Anti-Drug Antibody (ADA)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start18 May 2026
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693738
- Sponsor's protocol ID
- SSGJ-716-HV/AD-I-01
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07693738
- Acronym / sponsor ID
- SSGJ-716-HV/AD-I-01
- Conditions
- AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSGJ-716 | Experimental | Drug: SSGJ-716 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-716Single and multiple subcutaneous injection | Drug | SSGJ-716 |
| PlaceboSingle and multiple subcutaneous injection | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 85 days
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSGJ-716 in people with AD, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou (+86 189113015, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.