NCT07042113Not yet recruitingPhase 1
A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- Jul 2025
- Primary completion date
- Jan 2026
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07042113
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 180
- From Jul 2025 to the primary completion date, Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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;
- 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;
- 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;
Other illness
- History of severe allergies or allergies to 611 and any of its components;
- Any history of VKC and AKC;
- Have active tuberculosis;
Other
- Pregnant or lactating females;
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.