AsthmaPhase 1NCT02473939
An Evaluation of VR942 in Healthy Volunteers and Patients With Mild Asthma
A Phase 1 study testing VR942 delivered via a Vectura Dry Powder Inhaler in people with Asthma, run by Vectura Limited at 1 site in United Kingdom.
Trial summary
The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- VR942 delivered via a Vectura Dry Powder Inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Apr 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subject.
- Female subjects of non-childbearing potential
- Weigh at least 50 kg, and body mass index 18.0-31.0
- Peak inspiratory flow (PIF) of at least 60 L/min for at least 2 sec
- Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7 at the screening visit
- Willingness to give written consent to participate after reading the information and consent form
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- Willingness to give written consent to have data entered into The Over volunteering Prevention System.
- Additional inclusion criteria for Part 1:
- Healthy subjects with FEV1 and FVC of at least 80% of the predicted value at the screening visit
- Additional inclusion criteria for Part 2:
- Patients with documented clinical history of mild bronchial asthma (mild as defined by the GINA guidelines1) for at least 6 months before the screening visit
- Patient FEV1 and FVC of at least 70% of the predicted value at the screening visit
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous (excluding mild asthma in Part 2)
- Impaired endocrine, thyroid, hepatic, respiratory (excluding mild asthma in Part 2) or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness
- Respiratory tract infection within 4 weeks before the screening visit
- History of surgery or medical intervention, or planned surgery or medical intervention
- Presence or history of severe adverse reaction to any drug, or sensitivity to components of the trial medication
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- Use of a prescription or over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication. For Part 2 only, inhaled short-acting ß2 agonists, and ICS (stable dose with at least 2 weeks documented use of ≥80% compliance before screening and Day -1) are permitted
- Participation in another clinical trial of a new chemical entity, new device, or a prescription medicine within the 3 months before dosing, or participation within 5 half-lives of receiving an experimental drug (whichever is longer)
- Presence or history of drug or alcohol abuse
- Evidence of drug abuse on urine testing, or a positive test for alcohol
- Current smoker; or ex-smokers who (a) gave up less than 1 year ago, or (b) who have a history of more than 10 pack-years
- Blood pressure and heart rate at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min.
- Loss of more than 400 mL blood, eg as a blood donor, or donation of blood products, during the 3 months before the trial
- Positive test for hepatitis B, hepatitis C, or HIV
- Possibility that the subject will not cooperate with the requirements of the protocol, including effective use of the DPI
- Additional exclusion criteria for Part 2:
- Life-threatening asthmatic episode in the past
- Asthmatic episode or respiratory tract infection requiring steroid treatment in the past 3 months
- Use of the following medicines within the specified time before screening:
- Long-acting ß2 agonists; At any time before screening
- Anti IgE therapy; 6 months
- Inhaled corticosteroids (>500 µg per day of beclometasone dipropionate (BDP) or equivalent); 8 weeks
- Oral or injectable steroids; 8 weeks
- Intranasal or topical steroids; 4 weeks
- Leukotriene antagonists; 2 weeks
- Xanthines (excluding caffeine), anticholinergics, cromoglycates; 1 week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of VR942 in Healthy Subjects and Repeated Doses in Mild Asthmatics
The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2).
- Conditions
- Asthma
- Being tested
- VR942 delivered via a Vectura Dry Powder Inhaler, Placebo delivered via a Vectura Dry Powder Inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR942 delivered via a Vectura Dry Powder InhalerDrug
Placebo delivered via a Vectura Dry Powder InhalerDrug
| Study group | Role | What they receive |
|---|---|---|
| VR942 Dose 1 | Experimental | VR942 Dose 1 Receives: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler |
| VR942 Dose 2 | Experimental | VR942 Dose 2 Receives: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler |
| VR942 Dose 3 | Experimental | VR942 Dose 3 Receives: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler |
| VR942 Dose 4 | Experimental | VR942 Dose 4 Receives: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler |
| VR942 Dose 5 | Experimental | VR942 Dose 5 Receives: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics
- Vital signs, physical examinations, any AEs or adverse device effects, laboratory tests, spirometry, and ECG variables
Measured: 28 days
Secondary outcomes (3)
The pharmacodynamics of repeat doses of VR942 in mild asthmatics
- Change in biomarker levels
Measured: 28 days
The pharmacokinetic profile of single (Part 1) and repeated doses (part 2) of VR942 (time frame 4 and 14 days for Part 1 & 2 respectively):
Part 1:
Cmax, tmax, t½, AUC0-t, AUC0-∞ and Kel
Part 2:
Cmax, tmax, and AUC0-τ (post-dose on Day 1) Ctrough on Days 2, 9 and 10 Cmax, tmax, t½, AUC0-t, AUC0-τ, Kel (post-dose on Day 10) Accumulation ratio Racc (Cmax on Day 10/Cmax on Day 1), (AUC0-τ on Day 10/AUC0-τ on Day 1) and (Cmin on Day 10/Cmin on Day 2)
Measured: 4 and 14 days for Part 1 and 2 respectively
The number of used blisters and inhalers that do not meet the performance characteristics of the device intended by the manufacturer
- Examination of a sample of used blisters and inhalers will be conducted
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vectura Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473939
- Sponsor's protocol ID
- VR942/1/001
- Status last verified
- Dec 2016
- First submitted
- 29 May 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Burgess G, Boyce M, Jones M, Larsson L, Main MJ, Morgan F, Phillips P, Scrimgeour A, Strimenopoulou F, Vajjah P, Zamacona M, Palframan R. Randomized study of the safety and pharmacodynamics of inhaled interleukin-13 monoclonal antibody fragment VR942. EBioMedicine. 2018 Sep;35:67-75. doi: 10.1016/j.ebiom.2018.07.035. Epub 2018 Aug 23.
PubMed 30146344
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of VR942 in Healthy Subjects and Repeated Doses in Mild Asthmatics
- ClinicalTrials.gov ID
- NCT02473939
- Acronym / sponsor ID
- VR942/1/001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Vectura LimitedIndustry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- First posted
- 17 Jun 2015 (estimated)
- 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.
The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VR942 Dose 1 | Experimental | Drug: VR942 delivered via a Vectura Dry Powder Inhaler, Drug: Placebo delivered via a Vectura Dry Powder InhalerVR942 Dose 1 |
| VR942 Dose 2 | Experimental | Drug: VR942 delivered via a Vectura Dry Powder Inhaler, Drug: Placebo delivered via a Vectura Dry Powder InhalerVR942 Dose 2 |
| VR942 Dose 3 | Experimental | Drug: VR942 delivered via a Vectura Dry Powder Inhaler, Drug: Placebo delivered via a Vectura Dry Powder InhalerVR942 Dose 3 |
| VR942 Dose 4 | Experimental | Drug: VR942 delivered via a Vectura Dry Powder Inhaler, Drug: Placebo delivered via a Vectura Dry Powder InhalerVR942 Dose 4 |
| VR942 Dose 5 | Experimental | Drug: VR942 delivered via a Vectura Dry Powder Inhaler, Drug: Placebo delivered via a Vectura Dry Powder InhalerVR942 Dose 5 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female subject.
- Female subjects of non-childbearing potential
- Weigh at least 50 kg, and body mass index 18.0-31.0
- Peak inspiratory flow (PIF) of at least 60 L/min for at least 2 sec
- Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7 at the screening visit
Key exclusion criteria (26 listed)
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous (excluding mild asthma in Part 2)
- Impaired endocrine, thyroid, hepatic, respiratory (excluding mild asthma in Part 2) or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness
- Respiratory tract infection within 4 weeks before the screening visit
- History of surgery or medical intervention, or planned surgery or medical intervention
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 |
|---|---|---|
| VR942 delivered via a Vectura Dry Powder Inhaler | Drug | VR942 Dose 1, VR942 Dose 2, VR942 Dose 3, VR942 Dose 4, VR942 Dose 5 |
| Placebo delivered via a Vectura Dry Powder Inhaler | Drug | VR942 Dose 1, VR942 Dose 2, VR942 Dose 3, VR942 Dose 4, VR942 Dose 5 |
Primary outcome
Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics
Time frame: 28 days
o Vital signs, physical examinations, any AEs or adverse device effects, laboratory tests, spirometry, and ECG variables
3 secondary outcomes
The pharmacodynamics of repeat doses of VR942 in mild asthmatics
Time frame: 28 days
The pharmacokinetic profile of single (Part 1) and repeated doses (part 2) of VR942 (time frame 4 and 14 days for Part 1 & 2 respectively):
Time frame: 4 and 14 days for Part 1 and 2 respectively
The number of used blisters and inhalers that do not meet the performance characteristics of the device intended by the manufacturer
Time frame: 28 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 21 Dec 2016.
- Derived from this study: PubMed 30146344Burgess G, Boyce M, Jones M, Larsson L, Main MJ, Morgan F, Phillips P, Scrimgeour A, Strimenopoulou F, Vajjah P, Zamacona M, Palframan R. Randomized study of the safety and pharmacodynamics of inhaled interleukin-13 monoclonal antibody fragment VR942. EBioMedicine. 2018 Sep;35:67-75. doi: 10.1016/j.ebiom.2018.07.035. Epub 2018 Aug 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 VR942 delivered via a Vectura Dry Powder Inhaler in people with Asthma, run by Vectura 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 12 inclusion and 26 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 21 Dec 2016. 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. 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?
Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473939, which also lists 1 linked publication.
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 21 Dec 2016.