Trials / Completed
CompletedNCT04146129
A Phase 1 Study of CDX-0159
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Celldex Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a study to determine the safety of CDX-0159 in healthy subjects.
Detailed description
CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells. This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CDX-0159 | Single dose of one of four dosages of CDX-0159 |
| DRUG | Normal saline | Single infusion of normal saline |
Timeline
- Start date
- 2019-10-29
- Primary completion
- 2020-04-06
- Completion
- 2020-06-26
- First posted
- 2019-10-31
- Last updated
- 2020-07-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04146129. Inclusion in this directory is not an endorsement.