Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-29 @ 7:40 PM
Study NCT ID:
NCT04481594
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2020-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
Sponsor:
Hepanova Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo Controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPN-01
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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 study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
Detailed Description:
This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when HPN-01 is orally administered as single doses and as multiple doses to healthy subjects.
The study will be conducted in 2 parts: a single ascending dose (SAD) phase (Part 1) and a multiple ascending dose (MAD) phase (Part 2). One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01.
The study will be conducted in 2 parts: a single ascending dose (SAD) phase (Part 1) and a multiple ascending dose (MAD) phase (Part 2). One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01.
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?: