Atopic Dermatitis (AD)Phase 1NCT07411755
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
A Phase 1 study testing GS101 injection, U.S. commercial Dupixent® and CN commercial Dupixent® in people with Atopic Dermatitis (AD), run by Jiangsu Genscend Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- GS101 injection, U.S. commercial Dupixent® and CN commercial Dupixent®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2026to 24 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormalities detected in physical examination, vital signs, chest X-ray (posteroanterior [PA] view), 12-lead ECG, or laboratory tests prior to investigational product administration.
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive) and body weight between 55 and 85 kg (inclusive).
- Participants and their partner agree to use medically accepted contraceptive methods from the signing of the informed consent form until three months after dosing of the investigational product. In addition, participants have no plans to donate sperm, and their partner has no plans for pregnancy.
Who cannot join
- History or presence at screening of neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic/lymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments.
- History of drug or food allergy (≥2 types) or history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known hypersensitivity to monoclonal antibodies targeting the same pathway or to investigational product components.
- Positive result for any infectious disease screening, including human immunodeficiency virus (HIV) antibody and p24 antigen, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) IgG antibody, or Treponema pallidum (syphilis) antibody.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
About this study
Official title: A Randomized, Double-blind, Parallel, Single-dose, Phase 1 Clinical Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent® After Subcutaneous Injection
This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- GS101 injection, U.S. commercial Dupixent®, CN commercial Dupixent®
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS101 injectionDrug
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
U.S. commercial Dupixent®Drug
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
CN commercial Dupixent®Drug
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| GS101 injection | Experimental | Not described Receives: Drug: GS101 injection |
| U.S. commercial dupilumab (Dupixent®) | Active comparator | Not described Receives: Drug: U.S. commercial Dupixent® |
| China commercial dupilumab (Dupixent®) | Active comparator | Not described Receives: Drug: CN commercial Dupixent® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint
Cmax
Measured: 0-10 weeks
Pharmacokinetics Endpoint
AUC0-∞
Measured: 0-10 weeks
Pharmacokinetics Endpoint
AUC0-t
Measured: 0-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start5 Mar 2026
- Primary completion8 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Genscend Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411755
- Sponsor's protocol ID
- GS101-01
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel, Single-dose, Phase 1 Clinical Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent® After Subcutaneous Injection
- ClinicalTrials.gov ID
- NCT07411755
- Acronym / sponsor ID
- GS101-01
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Jiangsu Genscend Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 8 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 17 Feb 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.
This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GS101 injection | Experimental | Drug: GS101 injection |
| U.S. commercial dupilumab (Dupixent®) | Active comparator | Drug: U.S. commercial Dupixent® |
| China commercial dupilumab (Dupixent®) | Active comparator | Drug: CN commercial Dupixent® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No clinically significant abnormalities detected in physical examination, vital signs, chest X-ray (posteroanterior [PA] view), 12-lead ECG, or laboratory tests prior to investigational product administration.
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive) and body weight between 55 and 85 kg (inclusive).
- Participants and their partner agree to use medically accepted contraceptive methods from the signing of the informed consent form until three months after dosing of the investigational product. In addition, participants have no plans to donate sperm, and their partner has no plans for pregnancy.
Key exclusion criteria (3 listed)
- History or presence at screening of neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic/lymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments.
- History of drug or food allergy (≥2 types) or history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known hypersensitivity to monoclonal antibodies targeting the same pathway or to investigational product components.
- Positive result for any infectious disease screening, including human immunodeficiency virus (HIV) antibody and p24 antigen, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) IgG antibody, or Treponema pallidum (syphilis) antibody.
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 |
|---|---|---|
| GS101 injection300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions | Drug | GS101 injection |
| U.S. commercial Dupixent®300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions | Drug | U.S. commercial dupilumab (Dupixent®) |
| CN commercial Dupixent®300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions | Drug | China commercial dupilumab (Dupixent®) |
Primary outcome
Pharmacokinetics Endpoint
Time frame: 0-10 weeks
Cmax
Pharmacokinetics Endpoint
Time frame: 0-10 weeks
AUC0-∞
Pharmacokinetics Endpoint
Time frame: 0-10 weeks
AUC0-t
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 GS101 injection, U.S. commercial Dupixent® and CN commercial Dupixent® in people with Atopic Dermatitis (AD), run by Jiangsu Genscend Biopharmaceutical 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics Endpoint (time frame: 0-10 weeks). The study lists 3 primary outcomes in all. 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 15 Oct 2026.