Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-28 @ 4:58 AM
Study NCT ID:
NCT02758392
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2016-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Interventional Study of JNJ-61178104 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: