Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study to assess safety and tolerability of VM-1500 and to determine main pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Viriom

Criteria

Inclusion Criteria:

1. Provided signed written informed consent;

2. Healthy male subjects, 18-50 years of age;

3. Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.

4. ICF signed prior to any study-related procedure.

Exclusion Criteria:

1. HIV, hepatitis B, C antibodies in plasma;

2. Clinical relevant laboratory abnormalities;

3. Active tobacco, alcohol or drug abuse;

4. Anticipated non-compliance with the protocol;

5. Patients who have taken any investigational drug 3 months prior to the start of the study;

6. Plasma donorship, surgery 12 weeks prior to the start of the study;

7. Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.