Ignite Creation Date:
2025-12-18 @ 9:15 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT05354349
Status:
None
Last Update Posted:
2024-01-16 00:00:00
First Post:
2022-04-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers
Status:
None
Status Verified Date:
2024-01
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:
This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: