Study Examining PrEP-001 in Healthy Subjects

Hvivo

Status and phase: Completed; Phase 2

Conditions: Influenza A H3N2

Treatments: Drug: PrEP-001; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220048

PrEP-CS-001

Details and patient eligibility

About

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.

Full description

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 Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.

Volunteers remained in quarantine unit for 8 days after inoculation.

At day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.

Enrollment: 66 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Cohort A: Sentinel Group

Other group

Description:

Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.

Treatment:

Other: Placebo Comparator

Cohort B: PrEP-001

Experimental group

Description:

PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

Treatment:

Drug: PrEP-001

Cohort B: Placebo

Experimental group

Description:

Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

Treatment:

Other: Placebo Comparator