Atopic DermatitisPhase 1611NCT07042113
A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China
A Phase 1 study testing new formulations of 611 and existing formulations of 611 in people with Atopic Dermatitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 2 sites in China.
Trial summary
The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- new formulations of 611 and existing formulations of 611
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2025to Jan 2026
- 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
- Willingness to provide written informed consent for the study.
- Male or female subjects, age 18-45 years older.
- Within body mass index (BMI) range 19.0 to 26.0 kilograms per square meter (kg/m²).
- The results of vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray and other examinations during the screening period are normal or judged to be abnormal by the investigator and have no clinical significance.
- Males and females of non-childbearing potential.
Who cannot join
- History of severe allergies or allergies to 611 and any of its components;
- Previous or current disease that may affect the safety of the subject's participation in the trial or the in vivo process of the trial drug;
- Any history of VKC and AKC;
- History of drug abuse within 2 years prior to screening;
- Alcoholism within 3 months prior to screening;
- Those who smoke more than 5 cigarettes per day within 3 months before screening or cannot give up smoking during the period from signing the informed consent of the subject to leaving the group;
Show all 15Show fewer
- Those who have consumed more than 1L of strong tea, coffee and/or caffeinated beverages per day within 3 months before screening, and who have ingested chocolate or any food or drink containing caffeine, theophylline, theobromine or alcohol within 48 hours before the study administration;
- Have active tuberculosis;
- Presence of active infection requiring systemic treatment prior to screening or dosing;
- Those who have used any prescription drugs, over-the-counter drugs, vitamin products or Chinese herbal medicines within 4 weeks or 5 half lives (whichever is longer) before dosing, or those who may need to receive other drugs during the trial;
- Participated in the clinical trial of any drug or device within 3 months or 5 half-lives before dosing;
- Receipt of any marketed or investigational biologic within 3 months or 5 half lives prior to dosing;
- Live vaccine or live attenuated vaccine within 2 months prior to dosing or planned administration during the study;
- Previous use of any IL-4Rα target drugs;
- Pregnant or lactating females;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai General Hospital
Shanghai
XueYing Ding, Chief Pharmaceutist, +86 13761642319, dingxueying@126.com
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiangsheng
Ting Li, Director, +86 13587876896, liting1021@aliyun.com
About this study
Official title: A Randomized, Open-label, Parallel-enrollment Pharmacokinetic Comparison Study of Two Formulations of Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection (611) Injected Subcutaneously in Healthy Adult Subjects in China
The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.
Read the detailed description
This study is a randomized, open-label, parallel-designed comparative pharmacokinetic study to evaluate the biosimilarity between the formulations of 611.A total of about 180 healthy adult subjects in China were planned to be included, and the qualified subjects were randomly stratified according to the research center, body weight (≥65kg, <65kg), and randomly assigned to the test preparation group and the reference preparation group at a ratio of 1:1, and received a single subcutaneous injection of 300 mg of the experimental drug according to their group. Blood was collected on D1 and D2, D3, D4, D5, D6, D7, D8, D15, D22, D29, D43 and D57 after administration, respectively.
- Conditions
- Atopic Dermatitis
- Being tested
- new formulations of 611, existing formulations of 611
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new formulations of 611Drug
Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1
existing formulations of 611Drug
Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1
| Study group | Role | What they receive |
|---|---|---|
| Tested preparation group | Experimental | Healthy subjects will receive new formulations of 611 300mg once Receives: Drug: new formulations of 611 |
| Reference preparation group | Experimental | Healthy subjects will receive existing formulations of 611 300mg once Receives: Drug: existing formulations of 611 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 57 days
AUC
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042113
- Sponsor's protocol ID
- SSGJ-611-HV-I-02
- Acronym
- 611
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-enrollment Pharmacokinetic Comparison Study of Two Formulations of Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection (611) Injected Subcutaneously in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT07042113
- Acronym / sponsor ID
- 611 / SSGJ-611-HV-I-02
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Jun 2025 (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 main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.
Detailed description
This study is a randomized, open-label, parallel-designed comparative pharmacokinetic study to evaluate the biosimilarity between the formulations of 611.A total of about 180 healthy adult subjects in China were planned to be included, and the qualified subjects were randomly stratified according to the research center, body weight (≥65kg, <65kg), and randomly assigned to the test preparation group and the reference preparation group at a ratio of 1:1, and received a single subcutaneous injection of 300 mg of the experimental drug according to their group. Blood was collected on D1 and D2, D3, D4, D5, D6, D7, D8, D15, D22, D29, D43 and D57 after administration, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested preparation group | Experimental | Drug: new formulations of 611Healthy subjects will receive new formulations of 611 300mg once |
| Reference preparation group | Experimental | Drug: existing formulations of 611Healthy subjects will receive existing formulations of 611 300mg once |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willingness to provide written informed consent for the study.
- Male or female subjects, age 18-45 years older.
- Within body mass index (BMI) range 19.0 to 26.0 kilograms per square meter (kg/m²).
- The results of vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray and other examinations during the screening period are normal or judged to be abnormal by the investigator and have no clinical significance.
- Males and females of non-childbearing potential.
Key exclusion criteria (15 listed)
- History of severe allergies or allergies to 611 and any of its components;
- Previous or current disease that may affect the safety of the subject's participation in the trial or the in vivo process of the trial drug;
- Any history of VKC and AKC;
- History of drug abuse within 2 years prior to screening;
- Alcoholism within 3 months prior to screening;
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 |
|---|---|---|
| new formulations of 611Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1 | Drug | Tested preparation group |
| existing formulations of 611Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1 | Drug | Reference preparation group |
Primary outcome
Cmax
Time frame: 57 days
AUC
Time frame: 57 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 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing new formulations of 611 and existing formulations of 611 in people with Atopic Dermatitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 2 sites 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 15 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 57 days). The study lists 2 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 27 Jun 2025.