CompletedPhase 2

Study Examining PrEP-001 in Healthy Subjects

United Kingdom66 participantsStarted 2015-09-16

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).

Timeframe: 8 days

Trial details

NCT IDNCT03220048

SponsorHvivo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2019-09-12

View on ClinicalTrials.gov More Influenza A H3N2 trials