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NCT06324006

A Phase 1 Trial of LIB-01 in Healthy Participants.

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.
Dicot AB·Phase 1·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Erectile Dysfunction
Drug/Device/Intervention
LIB-01
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Dicot AB
Location
Uppsala, Sweden
Timeline & enrollment
Phase
Phase 1
Start date
Aug 25, 2023
End date
May 30, 2024
Enrollment
64 participants
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
Orgasmic dysfunctionOther disorders of penisOther specified disorders of penisSexual dysfunction, not caused by organic disorder or diseaseTesticular dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06324006
Type
Non-Device Trial
About this record

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.