A Phase 1 Trial of LIB-01 in Healthy Participants. - Trial NCT06324006
Access comprehensive clinical trial information for NCT06324006 through Pure Global AI's free database. This Phase 1 trial is sponsored by Dicot AB and is currently Recruitment Completed. The study focuses on Erectile Dysfunction. Target enrollment is 64 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Dicot AB
Timeline & Enrollment
Phase 1
Aug 25, 2023
May 30, 2024
Primary Outcome
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.,To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.,To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.,To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.,To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.,To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06324006
Non-Device Trial