NCT05031624

A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study of Single Ascending Doses of Subcutaneous CDX-0159 to Assess the Safety, Pharmacokinetics, and Pharmacodynamics 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 and pharmacokinetics of CDX-0159 administered subcutaneously 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. The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 administered subcutaneously in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	CDX-0159	Single subcutaneous dose of one of four dosages of CDX-0159
DRUG	Normal saline	Single subcutaneous dose of normal saline

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2021-09-02
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study