Trials / Active Not Recruiting
Active Not RecruitingNCT06324812
Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis
A Phase Ib/II Study to Evaluate the Safety, Pharmacokinetic and Efficacy of Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in Chinese Children and Adolescents (6 Years Old ≤ Age <18 Years Old) With Moderate to Severe Atopic Dermatitis
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) | subcutaneous injection，611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks |
Timeline
- Start date
- 2024-07-10
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2024-03-22
- Last updated
- 2025-12-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06324812. Inclusion in this directory is not an endorsement.