protocolSection identificationModule nctId: NCT06324006, orgStudyIdInfo id: DCT3934, briefTitle: A Phase 1 Trial of LIB-01 in Healthy Participants., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-25, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Dicot AB, class: INDUSTRY, descriptionModule briefSummary: 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-01Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:* Adverse events* ECG* Blood sampling for laboratory parameters and pharmacokinetic analysis, conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: LIB-01, interventions name: Placebo, outcomesModule primaryOutcomes measure: 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., primaryOutcomes measure: To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01., primaryOutcomes measure: To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01., primaryOutcomes measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01., primaryOutcomes measure: To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01., primaryOutcomes measure: To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01., secondaryOutcomes measure: To characterise the maximum plasma concentration of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the plasma concentration area under curve of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trial Consultants, city: Uppsala, zip: 75237, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False