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:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT03193203
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects aged 18-55 years
* Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive)
Exclusion Criteria:
* Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
* Have either active or latent TB or who have a history of TB
* Have clinically significant active infection within 4 weeks before the first IP administration
* Have had a history of serious infection
* Have previously been exposed to etanercept, if known
* Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
* Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03193203
Study Brief:
Protocol Section:
NCT03193203