A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China

NCT ID: NCT07042113

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-01-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tested preparation group

Healthy subjects will receive new formulations of 611 300mg once

Group Type: EXPERIMENTAL

new formulations of 611

Intervention Type: DRUG

Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1

Reference preparation group

Healthy subjects will receive existing formulations of 611 300mg once

Group Type: EXPERIMENTAL

existing formulations of 611

Intervention Type: DRUG

Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1

Interventions

new formulations of 611

Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1

Intervention Type: DRUG

existing formulations of 611

Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiangsheng, China

Shanghai General Hospital

Shanghai, , China

Countries

China

Central Contacts

Qinghong Zhou

Role: CONTACT

zhouqinghong@3sbio.com

+86 18911301578

Facility Contacts

Ting Li, Director

Role: primary

liting1021@aliyun.com

+86 13587876896

XueYing Ding, Chief Pharmaceutist

Role: primary

dingxueying@126.com

+86 13761642319

Other Identifiers

SSGJ-611-HV-I-02

Identifier Type: -

Identifier Source: org_study_id