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.

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: LIB-01; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75237
    • Clinical Trial Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Provision of signed and dated written informed consent prior to any trial specific procedures.
2. Healthy male participant aged 18 to 65 years, inclusive.
3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
4. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values.
5. Participants must be willing to use an acceptable form of contraception and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use an acceptable contraceptive method from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.
6. Understands the trial requirements.
7. MAD participants only: Mild to moderate erectile dysfunction.

Exclusion criteria

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
4. Any planned major surgery within the duration of the trial.
5. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to LIB-01.
6. History of priapism.
7. History of glaucoma.
8. History of Non-Arteritic Anterior Ischemic Optic Neuropathy.
9. History of prostatectomy or prostate surgery.
10. Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk.
11. Cardiac disease, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
12. Any positive result for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
13. Abnormal vital signs.
14. Shortened QT interval corrected according to Fridericia (QTcF), prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant ECG abnormalities.
15. Use of oral, injectable, or topical pro-erectile drugs or supplements.
16. Use of nitrates.
17. Ongoing antiandrogen treatment.
18. Regular use of any prescribed or non-prescribed medications, within 2 weeks (Part I:SAD) or 4 weeks (Part II: MAD) prior to the (first) administration of IMP, except occasional intake of paracetamol, as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days.
19. Planned treatment or treatment with another investigational drug.
20. Current smokers or users of nicotine products.
21. Positive screening result for drugs of abuse or alcohol.
22. History of alcohol abuse or excessive intake of alcohol.
23. Presence or history of drug abuse.
24. History of, or current use of anabolic steroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIB-01; LIB-01 oral suspension	Drug: LIB-01; LIB-01 oral suspension
Placebo Comparator: Placebo; Placebo oral suspension	Other: Placebo; Placebo oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	14 days
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.	Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).	14 days
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.	Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).	14 days
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.	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.	28 days
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.	Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).	28 days
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.	Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dicot AB
• Investigators: Principal Investigator: Björn Schultze, MD, CTC

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: DCT3934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No