Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT02758392
Brief Summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.
Study:
NCT02758392
Study Brief:
Protocol Section:
NCT02758392