Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04819620
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of PN-232 in Healthy Volunteers
Sponsor:
Protagonist Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-09
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 Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.
Detailed Description:
Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.
Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.
In total, approximately 84 subjects will participate.
Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.
In total, approximately 84 subjects will participate.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: