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

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ClinicalTrials.gov Identifier: NCT03198676
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Prep Biopharm Limited

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 26, 2017
Last Update Posted Date July 2, 2017
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date May 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
Changes in baseline in nasal mucosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
Changes in baseline in nasal muscosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
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)
Change History Complete list of historical versions of study NCT03198676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
  • Changes in baseline in nasal mucosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
    Changes from baseline in nasal mucosal secretions and serum cytokine concentrations when dosed for up to 5 days with PrEP 001 Nasal Powder 6.4 mg Formulation B and matching placebo Formulation B
  • Changes in baseline in nasal mucosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
    Changes from baseline in nasal mucosal secretions and serum cytokine concentrations when dosed for up to 5 days with PrEP-001 Nasal Powder (3.2 mg and 6.4 mg Formulation B
  • Assessment of safety parameters [ Time Frame: 5 days ]
    Assessment of the following safety variables: physical examination, safety laboratory tests, vital signs, ECGs and AEs (Formulation B vs Formulation A)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
  • Changes in baseline in nasal muscosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
    Changes from baseline in nasal mucosal secretions and serum cytokine concentrations when dosed for up to 5 days with PrEP 001 Nasal Powder 6.4 mg Formulation B and matching placebo Formulation B
  • Changes in baseline in nasal muscosal secretions and serum cytokine concentrations [ Time Frame: 5 days ]
    Changes from baseline in nasal mucosal secretions and serum cytokine concentrations when dosed for up to 5 days with PrEP-001 Nasal Powder (3.2 mg and 6.4 mg Formulation B
  • Assessment of safety parameters [ Time Frame: 5 days ]
    Assessment of the following safety variables: physical examination, safety laboratory tests, vital signs, ECGs and AEs (Formulation B vs Formulation A)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production
Official Title  ICMJE A Single Centre, Partially Blinded, Randomised Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production in Healthy Human Volunteers
Brief Summary A safety study to compare the effect of two different formulations of PrEP-001 nasal powder when dosed in healthy subjects
Detailed Description A single centre, randomised, partially blinded placebo-controlled repeat dose study in healthy male subjects to compare the effect of two different formulations of PrEP-001 nasal powder on nasal mucosal and serum cytokine profiles when dosed for up to five days in health subjects and provide additional safety and tolerability information on active PrEP-001 nasal powder.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Randomised partially blinded, partially placebo controlled, repeat dose
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Upper Respiratory Tract Infections
Intervention  ICMJE
  • Drug: PrEP-001 6.4 mg
    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
    Other Name: Poly-IC
  • Drug: PrEP-001 6.4 mg
    6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
    Other Name: Poly-IC
  • Drug: PrEP-001 3.2 mg
    3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device
    Other Name: Poly-IC
  • Drug: Placebo
    2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
Study Arms  ICMJE
  • Active Comparator: A - PrEP-001 6.4 mg - 0.8 mg/spray
    PrEP-001 Nasal Powder, 0.8 mg/spray (G-006) (Formulation A)
    Intervention: Drug: PrEP-001 6.4 mg
  • Active Comparator: B - PrEP-001 6.4 mg - 1.6 mg/spray
    PrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B)
    Intervention: Drug: PrEP-001 6.4 mg
  • Active Comparator: C - PrEP-001 3.2 mg - 1.6 mg/spray
    PrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B)
    Intervention: Drug: PrEP-001 3.2 mg
  • Placebo Comparator: D - Placebo
    PrEP-001 Placebo Nasal Powder (matching Formulation B)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 24, 2017
Actual Primary Completion Date May 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 concurrent serious illness (eg diagnosis of severe depression, pulmonary hypertension, history of malignancy) that may interfere with a subject completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion
  • 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
  • Has experienced upper or lower respiratory infection (viral, fungal or bacterial) that resolved less than 4 weeks before Day 1
  • Has required antibiotic treatment for a lower respiratory tract infection in the 3 months prior to the study
  • Subjects with a significant nasal condition eg Wegener's granulomatosis, that could interfere with study assessments
  • Any significant abnormality altering the anatomy of the nose or nasopharynx on examination
  • Any nasal or sinus surgery within 6 months of Day 1
  • Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or history of being hospitalised due to epistaxis on any previous occasion
  • History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic eczema/atopic dermatitis. Subjects with clinically mild atopic eczema/atopic dermatitis may be included at the Investigator's discretion (eg if there is no regular use of topical steroids, no eczema in cubital fossa)
  • Subjects with known history of Immunosuppression or known chronic viral infection
  • Has active seasonal or perennial nasal/pharyngeal allergies at screening visit; or anticipates to have such symptoms during the study duration; or has had symptoms in the 4 weeks prior to Day 1
  • Presence or history of clinically significant allergy requiring treatment (including food or drug allergy), as judged by the investigator
  • Known allergy or adverse reaction history to formulation components
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor
  • Failure to satisfy the investigator of fitness to participate for any other reason
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03198676
Other Study ID Numbers  ICMJE PrEP-001-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prep Biopharm Limited
Study Sponsor  ICMJE Prep Biopharm Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Litza McKenzie, MBChB BSc Quotient Clinical
PRS Account Prep Biopharm Limited
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP