NCT06650761

A Phase I Study of CDX-622

A Randomized, Double-Blind, Placebo-Controlled, Three-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (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-622 in healthy participants.

Detailed description

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). This study will evaluate the safety, pharmacokinetics, and Pharmacodynamics of IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	CDX-622	Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622
DRUG	Normal Saline	Up to 4 infusions or 6 SC injections of normal saline

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-10-21
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study