A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production

NCT03198676 | Completed Phase 1 FDA Drug

• 1 other identifier: PrEP-001-104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A safety study to compare the effect of two different formulations of PrEP-001 nasal powder when dosed in healthy subjects

Conditions

Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Changes in baseline in nasal mucosal secretions and serum cytokine concentrations

  Changes from baseline in nasal mucosal secretions and serum cytokine concentrations when dosed for up to 5 days with 2 different formulations of PrEP 001 Nasal Powder (ie 6.4 mg Formulation B vs 6.4 mg Formulation A)

  5 days

Secondary Outcomes (3)

• Changes in baseline in nasal mucosal secretions and serum cytokine concentrations

  5 days

• Changes in baseline in nasal mucosal secretions and serum cytokine concentrations

  5 days

• Assessment of safety parameters

  5 days

Study Arms (4)

A - PrEP-001 6.4 mg - 0.8 mg/spray

ACTIVE COMPARATOR

PrEP-001 Nasal Powder, 0.8 mg/spray (G-006) (Formulation A)

Drug: PrEP-001 6.4 mg

B - PrEP-001 6.4 mg - 1.6 mg/spray

ACTIVE COMPARATOR

PrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B)

Drug: PrEP-001 6.4 mg

C - PrEP-001 3.2 mg - 1.6 mg/spray

ACTIVE COMPARATOR

PrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B)

Drug: PrEP-001 3.2 mg

D - Placebo

PLACEBO COMPARATOR

PrEP-001 Placebo Nasal Powder (matching Formulation B)

Drug: Placebo

Interventions

PrEP-001 6.4 mg DRUG

6.4 mg as 4 sprays per nostril (ie total of 8 sprays for a single dose) using Aptar unit dose strength powder (UDSP) device

Also known as: Poly-IC

A - PrEP-001 6.4 mg - 0.8 mg/spray

PrEP-001 3.2 mg DRUG

3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device

Also known as: Poly-IC

C - PrEP-001 3.2 mg - 1.6 mg/spray

Placebo DRUG

2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device

D - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males
• Aged 18 to 65 years
• A body weight of \>50 kg and body mass index .18.0 to \<32.0 kg/m2
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who have smoked within the last 12 months. A confirmed positive urine cotinine test at screening and admission
• Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
• Subject who have significant history of any tobacco use at any time (total ≥10 pack years history)
• Subjects who do not have suitable veins for multiple venepunctures as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
• Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
• Any chronic medical condition that could significantly reduce the ability of the subject to participate in the study or pose a safety concern eg unstable angina, uncontrolled diabetes mellitus, anaemia
• Any finding in the medical history review, physical examination (including nasal exam with nasal speculae), screening investigations, that in the opinion of the investigator would compromise the subject's ability to safely complete the study

Sponsors & Collaborators

• Prep Biopharm Limited: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Poly I-C

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Poly C; Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Poly I

Study Officials

• Litza McKenzie, MBChB BSc

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised partially blinded, partially placebo controlled, repeat dose

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 26, 2017
• Study Start: May 8, 2017
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)