NCT07358156

A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

A Randomised, Double-blind, Three-arm, Parallel Group, Single Dose, Phase 1 Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 519 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, three-arm, parallel group, single-dose, Phase 1 comparative study of CKD-706, US-Dupixent, and EU-Dupixent in healthy adult participants.

Detailed description

Dosing the CKD-706, US Dupixent, or EU-Dupixent 300 mg at Day 1. Blood samples for Pharmacokinetic analysis will be collected on Day 1 - 85. Blood sample for Pharmacodynimic and immunogenicity analysis will be collected on Day 1 - 85.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	CKD-706	One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL
DRUG	US-Dupixent	One subcutaneous dose of US-Dupixent in pre-filled syringe, 300 mg/2mL
DRUG	EU-Dupixent	One subcutaneous dose of EU-Dupixent in pre-filled syringe, 300 mg/2mL

Timeline

• Start date: 2026-02-09
• Primary completion: 2026-11-16
• Completion: 2026-11-16
• First posted: 2026-01-22
• Last updated: 2026-01-23

Locations

2 sites across 2 countries: Germany, United Kingdom

Regulatory

• FDA-regulated drug study