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ClinicalTrials.gov ID

NCT07042113

Lead Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

180Estimated

Last Update Posted

Jun 27, 2025Actual

Start Date

Jul 2025Estimated

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

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

Brief 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.

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.

• Atopic Dermatitis

• new formulations of 611
• existing formulations of 611

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Willingness to provide written informed consent for the study.
2. Male or female subjects, age 18-45 years older.
3. Within body mass index (BMI) range 19.0 to 26.0 kilograms per square meter (kg/m²).
4. 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.
5. Males and females of non-childbearing potential.

Exclusion Criteria:

1. History of severe allergies or allergies to 611 and any of its components;
2. 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;
3. Any history of VKC and AKC;
4. History of drug abuse within 2 years prior to screening;
5. Alcoholism within 3 months prior to screening;
6. 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;
7. 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;
8. Have active tuberculosis;
9. Presence of active infection requiring systemic treatment prior to screening or dosing;
10. 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;
11. Participated in the clinical trial of any drug or device within 3 months or 5 half-lives before dosing;
12. Receipt of any marketed or investigational biologic within 3 months or 5 half lives prior to dosing;
13. Live vaccine or live attenuated vaccine within 2 months prior to dosing or planned administration during the study;
14. Previous use of any IL-4Rα target drugs;
15. Pregnant or lactating females;

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.INDUSTRY

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