Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:53 PM
Study NCT ID:
NCT06324006
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2023-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Trial of LIB-01 in Healthy Participants.
Sponsor:
Dicot AB
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Parallel and Placebo-controlled Single and Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of LIB-01 in Healthy Participants.
Status:
COMPLETED
Status Verified Date:
2024-05
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 goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:
* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
* What are the pharmacokinetic characteristics of LIB-01
Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:
* Adverse events
* ECG
* Blood sampling for laboratory parameters and pharmacokinetic analysis
* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
* What are the pharmacokinetic characteristics of LIB-01
Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:
* Adverse events
* ECG
* Blood sampling for laboratory parameters and pharmacokinetic analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: