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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523115-11-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 173 healthy participants receiving one dose of investigational medical product |
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| Arm 2 | Active Comparator | 173 healthy participants receiving one dose of investigational medical product |
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| Arm 3 | Active Comparator | 173 healthy participants receiving one dose of investigational medical product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-706 | Drug | One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) | Day 1 - 85. | |
| Area under the concentration-time curve from time zero up to infinity (AUC0-inf) | Day 1 - 85. | |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) | Day 1 - 85. |
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Inclusion Criteria:
Participant is capable of giving signed informed consent
Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture.
Body-mass index between 18.5 - 29.9 kg/m2 (inclusive) with body weight ≥ 50 kg and < 95 kg at screening.
Participant agrees to be available for the entire duration of the study
All female participants must have a negative serum pregnancy test at the screening visit and on admission to the Clinical Unit (Day -1).
Female Participants:
• A female participant is eligible to participate if she is not pregnant, not be lactating and not breastfeeding, and at least one of the following conditions applies
Male Participants • Male participants and their female spouse/partners who are of childbearing potential must be using 2 forms of birth control from screening until at least 3 months after the end of study intervention dose.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Rincon | Contact | +49 30 306851306 | camila.rincon@parexel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel EPCU Berlin | Not yet recruiting | Berlin | State of Berlin | 10115 | Germany |
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| 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 |
|
| Parexel EPCU London | Recruiting | London | England | HA1 3UJ | United Kingdom |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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