Study Examining PrEP-001 in Healthy Subjects

Launched by HVIVO · Jul 14, 2017

Keywords

ClinConnect Summary

Screening took place up to 90 days before quarantine. Volunteers completed an informed consent and underwent screening assessments to determine their eligibility.

There were 2 study groups:

Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.

Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on Da...

Gender

ALL

Eligibility 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