Trials / Completed
CompletedNCT04172233
A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
A Randomized, Double-blinded, and Placebo-controlled Phase I/II Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Akeso · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis.
Detailed description
This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AK101 | AK101 is an anti-IL-12/23p40 monoclonal antibody. |
| BIOLOGICAL | placebo | matching placebo |
Timeline
- Start date
- 2018-01-09
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2019-11-21
- Last updated
- 2025-03-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04172233. Inclusion in this directory is not an endorsement.