Study Examining PrEP-001 in Healthy Subjects

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hvivo
• Collaborator: Prep Biopharm Limited

Criteria

Inclusion Criteria:

• Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.

• Female subjects were required to provide of a history of reliable contraceptive practice.

Exclusion criteria:

• Subjects who have a significant history of any tobacco use at any time.

• Any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease.

• Abnormal ECG