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

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT07358156
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Feb 9, 2026
Status verified
Jan 2026
Primary completion
Nov 16, 2026
Completion
Nov 16, 2026

Study Design

Enrollment
519 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    173 healthy participants receiving one dose of investigational medical product
  • Active Comparator: Arm 2
    173 healthy participants receiving one dose of investigational medical product
  • Active Comparator: Arm 3
    173 healthy participants receiving one dose of investigational medical product

Primary Outcome Measure

Maximum serum concentration (Cmax) [ Time Frame: Day 1 - 85. ]

Central Contacts

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