Study to compare PK & Safety of CKD-706 with US-Dupixent & EU-Dupixent in HV
Research type
Research Study
Full title
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of CKD-706 with US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants
IRAS ID
1012862
Contact name
Juhee Yim
Contact email
Sponsor organisation
Chong Kun Dang Pharmaceutical Corp.
Eudract number
0000-000000-00
Clinicaltrials.gov Identifier
Research summary
This is a first-in-human trial conducted at two sites approximately 519 healthy male and female participants.
The main purpose of the trial is to compare the trial medicine, CKD-706, with the reference product Dupixent® (approved as Dupixent® in Europe and the USA for treatment of chronic inflammatory diseases); all containing the active ingredient dupilumab. The pharmacokinetics (amount of trial medicine in the body over time) of CKD-706, EU- and US-Dupixent® will be evaluated after administration under the skin. The trial will also investigate how safe CKD-706 is and how well it is tolerated. The effect of the CKD-706 on the body will be assessed (pharmacodynamics) and the extent to which CKD-706 triggers an immune response (immunogenicity). Dupilumab is an antibody (protein produced by the body).
The trial consists of a Screening Period of up to 42 days. Dosing will be performed on Day 1. Participants will stay in the Clinical Unit until up to 48 hours after dosing. All participants will be followed up until Day 85 when a final Follow-up Visit will take place.
Single dose of 300 mg of either CKD-706, US-Dupixent®, or EU-Dupixent® will be given to 173 participants (in three treatment groups), each in a double-blind, randomised trial design. For safety purposes, only 1 participant in each treatment group will receive a dose initially and will be observed for 48 hours after administration. If no serious side effects occur, 2 additional participants in each treatment group will receive a dose and will again be observed for at least 48 hours. If safety and tolerability data for these participants are satisfactory 48 hours after administration, the remaining participants in each treatment group will be dosed.
CKD-706 is being developed by CKD for the treatment of chronic inflammatory diseases.
No human safety data is available yet. Based on the available date on the active ingredient, no clinically significant undesirable effects are expected.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0277
Date of REC Opinion
7 Jan 2026
REC opinion
Further Information Favourable Opinion