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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: LIB-01; Other: Placebo

• Registration Number: NCT06324006
• Lead Sponsor: Dicot AB

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-25
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-21
• Primary Completion: 2024-04-23
• Status Verified: 2024-05
• Study Completion: 2024-05-29
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIB-01	LIB-01	LIB-01 oral suspension
Placebo	Placebo	Placebo oral suspension

Primary Outcome Measures

Name	Time	Method
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.	14 days	Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.; Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).; Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.; Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.	14 days	Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.	14 days	Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.	28 days	Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.; Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).; Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.; Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE. Clinically significant changes in vital signs, ECG and safety laboratory measurements.
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.	28 days	Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.	28 days	Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).

Secondary Outcome Measures

Name	Time	Method
To characterise the maximum plasma concentration of LIB-01, following a single oral dose.	3 days	Maximum Plasma Concentration \[Cmax\]
To characterise the plasma concentration half life of LIB-01, following a single oral dose.	3 days	Plasma Concentration Half Life \[T1/2\]
To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.	3 days	Plasma Concentration Area Under Curve \[AUC\]
To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.	4 days	Maximum Plasma Concentration \[Cmax\]
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.	4 days	Plasma Concentration Area Under Curve \[AUC\]

Trial Locations

Locations (1)

Clinical Trial Consultants; 🇸🇪 Uppsala, Sweden