MedTrace Logo

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

NCT06324006 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-05-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

LIB-01

LIB-01 oral suspension

OTHER

Placebo

Placebo oral suspension

Sponsors & Collaborators

  • Dicot AB

    lead INDUSTRY

Principal Investigators

  • Björn Schultze, MD · CTC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2024-04-23
Completion
2024-05-29

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324006 on ClinicalTrials.gov