Study Examining PrEP-001 in Healthy Subjects

NCT ID: NCT03220048

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-16
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Conditions

Influenza A H3N2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cohort A: Sentinel Group

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

Group Type: OTHER

Placebo Comparator

Intervention Type: OTHER

Cohort B: PrEP-001

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.

Group Type: EXPERIMENTAL

PrEP-001

Intervention Type: DRUG

Cohort B: Placebo

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.

Group Type: EXPERIMENTAL

Placebo Comparator

Intervention Type: OTHER

Interventions

PrEP-001

Intervention Type: DRUG

Placebo Comparator

Intervention Type: OTHER

Other Intervention Names

JNJ-43260295-AAM; G-004

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prep Biopharm Limited

INDUSTRY

Sponsor Role: collaborator

Hvivo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Efthimiou

Role: STUDY_CHAIR

Sponsor's representative

Locations

hVIVO Services Ltd, QMB Bioenterprise building

London, , United Kingdom

Countries

United Kingdom

References

Malcolm BA, Aerts CA, Dubois KJ, Geurts FJ, Marien K, Rusch S, Van Dijck AH, Verloes R, Vingerhoets J. PrEP-001 prophylactic effect against rhinovirus and influenza virus - RESULTS of 2 randomized trials. Antiviral Res. 2018 May;153:70-77. doi: 10.1016/j.antiviral.2018.03.005. Epub 2018 Mar 19.

Reference Type: DERIVED

PMID: 29567461 (View on PubMed)

Other Identifiers

PrEP-CS-001

Identifier Type: -

Identifier Source: org_study_id