NCT05641558

Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the safety and tolerability of 611 in chinese adults with moderate to severe atopic dermatitis.

Detailed description

The maximum study duration was 30 weeks per participants, including a screening period of up to 2 weeks, a 4-weeks single dose treatment period, and then a 16-weeks repeated dose treatment period, and an 8-week follow-up period.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	611 150mg	subcutaneous injection, 150 mg (single dose treatment period) + 300mg (loading dose, week 0) + 150mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)
DRUG	611 300mg	subcutaneous injection, 300 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 1 to Week 15, 8 cycles)
DRUG	611 600mg	subcutaneous injection, 600 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)
OTHER	Placebo	During the study, placebos shall be filled timely according to the administration of the test drug to ensure the consistency of the times of administration in each group, so as to maintain the blind state.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

5 sites across 1 country: China