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

NCT07042113 | Not Yet Recruiting Phase 1

• 1 other identifier: SSGJ-611-HV-I-02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Cmax

  57 days

• AUC

  57 days

Study Arms (2)

Tested preparation group

EXPERIMENTAL

Healthy subjects will receive new formulations of 611 300mg once

Drug: new formulations of 611

Reference preparation group

EXPERIMENTAL

Healthy subjects will receive existing formulations of 611 300mg once

Drug: existing formulations of 611

Interventions

new formulations of 611 DRUG

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

Tested preparation group

existing formulations of 611 DRUG

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

Reference preparation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (2)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiangsheng, China

Location

Shanghai General Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Qinghong Zhou

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)