Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04532567
Eligibility Criteria:
Inclusion Criteria:
* Caucasian and Japanese male between 20-55 years of age (extremes included), on the date of signing the informed consent form (ICF).
* Japanese subjects must be first generation Japanese of full Japanese parentage, and must have not lived outside Japan for more than 5 years. First generation subjects will have been born in Japan of 2 parents and 4 grandparents also born in Japan of full Japanese descent.
* A body mass index (BMI) between 18-26 kg/m2, extremes included, with a minimum body weight of 45 kg.
* Able and willing to comply with the protocol requirements and signing the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
Exclusion Criteria:
* History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to the investigational product (IP) or its excipients as determined by the investigator.
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT04532567
Study Brief:
Protocol Section:
NCT04532567