Trials / Completed
CompletedNCT04893941
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Keymed Biosciences Co.Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM310 | IL-4Rα monoclonal antibody |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2021-01-22
- Completion
- 2021-01-22
- First posted
- 2021-05-20
- Last updated
- 2021-06-04
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04893941. Inclusion in this directory is not an endorsement.