Upper Respiratory Tract InfectionsPhase 1NCT03198676
A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production
A Phase 1 study testing PrEP-001 6.4 mg and PrEP-001 3.2 mg in people with Upper Respiratory Tract Infections, run by Prep Biopharm Limited at 1 site in United Kingdom.
Trial summary
A safety study to compare the effect of two different formulations of PrEP-001 nasal powder when dosed in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- PrEP-001 6.4 mg and PrEP-001 3.2 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2017to 24 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A safety study to compare the effect of two different formulations of PrEP-001 nasal powder when dosed in healthy subjects
Read the 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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- PrEP-001 6.4 mg, PrEP-001 3.2 mg, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP-001 6.4 mgDrug
Also called Poly-IC
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
PrEP-001 6.4 mgDrug
Also called Poly-IC
6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
PrEP-001 3.2 mgDrug
Also called Poly-IC
3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device
PlaceboDrug
2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
| Study group | Role | What they receive |
|---|---|---|
| A - PrEP-001 6.4 mg - 0.8 mg/spray | Active comparator | PrEP-001 Nasal Powder, 0.8 mg/spray (G-006) (Formulation A) Receives: 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) Receives: 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) Receives: Drug: PrEP-001 3.2 mg |
| D - Placebo | Placebo comparator | PrEP-001 Placebo Nasal Powder (matching Formulation B) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 days
Secondary outcomes (3)
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 PrEP 001 Nasal Powder 6.4 mg Formulation B and matching placebo Formulation B
Measured: 5 days
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 PrEP-001 Nasal Powder (3.2 mg and 6.4 mg Formulation B
Measured: 5 days
Assessment of safety parameters
Assessment of the following safety variables: physical examination, safety laboratory tests, vital signs, ECGs and AEs (Formulation B vs Formulation A)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start8 May 2017
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomised partially blinded, partially placebo controlled, repeat dose
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prep Biopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MBChB BSc, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198676
- Sponsor's protocol ID
- PrEP-001-104
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03198676
- Acronym / sponsor ID
- PrEP-001-104
- Conditions
- Upper Respiratory Tract Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prep Biopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomised partially blinded, partially placebo controlled, repeat dose
| Arm | Type | Receives |
|---|---|---|
| A - PrEP-001 6.4 mg - 0.8 mg/spray | Active comparator | Drug: PrEP-001 6.4 mgPrEP-001 Nasal Powder, 0.8 mg/spray (G-006) (Formulation A) |
| B - PrEP-001 6.4 mg - 1.6 mg/spray | Active comparator | Drug: PrEP-001 6.4 mgPrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B) |
| C - PrEP-001 3.2 mg - 1.6 mg/spray | Active comparator | Drug: PrEP-001 3.2 mgPrEP-001 Nasal Powder, 1.6 mg/spray (F002) (Formulation B) |
| D - Placebo | Placebo comparator | Drug: PlaceboPrEP-001 Placebo Nasal Powder (matching Formulation B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP-001 6.4 mgAlso: Poly-IC6.4 mg as 4 sprays per nostril (ie total of 8 sprays for a single dose) using Aptar unit dose strength powder (UDSP) device | Drug | A - PrEP-001 6.4 mg - 0.8 mg/spray |
| PrEP-001 6.4 mgAlso: Poly-IC6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device | Drug | B - PrEP-001 6.4 mg - 1.6 mg/spray |
| PrEP-001 3.2 mgAlso: Poly-IC3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device | Drug | C - PrEP-001 3.2 mg - 1.6 mg/spray |
| Placebo2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device | Drug | D - Placebo |
Primary outcome
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)
3 secondary outcomes
Changes in baseline in nasal mucosal secretions and serum cytokine concentrations
Time frame: 5 days
Changes in baseline in nasal mucosal secretions and serum cytokine concentrations
Time frame: 5 days
Assessment of safety parameters
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Litza McKenzie, MBChB BSc principal investigator
Quotient Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PrEP-001 6.4 mg and PrEP-001 3.2 mg in people with Upper Respiratory Tract Infections, run by Prep Biopharm Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in baseline in nasal mucosal secretions and serum cytokine concentrations (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.