Phase 2a Trial to Investigate the Efficacy of LIB-01 in Treatment of Erectile Dysfunction

Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any trial specificprocedures.

2. Male participant aged 25 to 65 years, inclusive, at the screening visit.

3. In a stable heterosexual relationship for at least 6 months prior to the screeningvisit.

4. Total score of 11-25 on questions 1-5 and 15 on the EF domain of the IIEFquestionnaire.

5. Highly motivated to obtain treatment for ED.

6. Willing to abstain from unprotected sex and use condom to prevent drug exposure of apartner and pregnancy from first dose until the end-of-trial. In addition, refrainfrom donating sperm from the date of dosing until 3 months after (last) dosing withthe IMP. Any female partner of child-bearing potential of a non-vasectomised trialparticipant must use contraceptive methods with a failure rate of < 1% to preventpregnancy until the end-of-trial visit.

7. Understands the trial requirements.

Exclusion Criteria:

1. History of any clinically significant disease or disorder, including psychiatricdisorder, which, in the opinion of the Investigator, may either put the participantat risk because of participation in the trial, or influence the results or theparticipant's ability to participate in the trial.

2. Type 1 diabetes.

3. Haemoglobin A1c (HbA1c) ≥48 mmol/L (6.5%).

4. Any clinically significant illness, medical/surgical procedure or trauma within 4weeks of the first administration of IMP.

5. Malignancy within the past 5 years, with the exception of in situ removal of basalcell carcinoma.

6. Any planned major surgery within the duration of the trial.

7. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, asjudged by the Investigator, or history of hypersensitivity to drugs with a similarchemical structure or class to LIB-01 API.

8. History of priapism, or increased risk due to underlying illness, including but notlimited to hemoglobinopathies such as sickle cell anaemia or thalassemia.

9. History of glaucoma.

10. History of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).

11. History of prostatectomy.

12. History of alcohol abuse or excessive intake of alcohol, as judged by theInvestigator.

13. Presence or history of drug abuse, as judged by the Investigator.

14. History of, or current use of anabolic steroids, as judged by the Investigator.

15. Bleeding deficiencies or ongoing anticoagulant therapy that would put theparticipant at risk, as judged by the investigator.

16. Uncontrolled cardiac disease within 6 months of screening, including but not limitedto uncontrolled hypertension; unstable angina; myocardial infarction orcerebrovascular accident.

17. Use of nitrate medications within 14 days prior to the screening visit.

18. Use of any drug with narrow therapeutic index or drugs that are sensitivesubstrates, strong inducers or strong inhibitors to CYP3A4 as well as substrates andinhibitors of OATP1B1 or sensitive to substrates to CYP2B6 in accordance with thelist provided (see Section 9.6.2.1).

19. Use of oral, injectable, intra-urethral, or topical pro-erectile drugs orsupplements, including but not limited to PDE5-Is or prostaglandin E1, or use ofdevices for ED treatment, within 14 days prior to screening.

20. Primary hypoactive sexual desire.

21. Presence of penile anatomical abnormalities, such as penile fibrosis or Peyronie'sdisease, which would cause significantly impaired sexual performance, as judged bythe Investigator.

22. Insufficient therapeutic effect when using PDE5-Is.

23. History of, or ongoing antiandrogen treatment.

24. Any positive result at the screening visit for serum hepatitis B surface antigen,hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).

25. Abnormal vital signs, laboratory test value or ECG of clinical significance, asjudged by the Investigator.

26. Moderate to severe renal impairment with an eGFR (creatinine) ≤60 mL/min (revisedMalmö-Lund equation).

27. Moderate to severe hepatic impairment at the time of the screening visit, as judgedby the Investigator.

28. Plasma donation within one month of screening or blood donation (or correspondingblood loss) during the last three months prior to the screening visit.

29. Planned treatment or treatment with another investigational therapy (i.e., smallmolecule or biologic) within 3 months prior to the screening visit.

30. Involvement in the planning, and/or conduct of the trial.

31. The Investigator considers the participant unlikely to comply with trial procedures,restrictions and requirements.