An Evaluation of VR942 in Healthy Volunteers and Patients With Mild Asthma
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
1 other identifier
interventional
85
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedDecember 21, 2016
December 1, 2016
10 months
May 29, 2015
December 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
o Vital signs, physical examinations, any AEs or adverse device effects, laboratory tests, spirometry, and ECG variables
28 days
Secondary Outcomes (3)
The pharmacodynamics of repeat doses of VR942 in mild asthmatics
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):
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
28 days
Study Arms (5)
VR942 Dose 1
EXPERIMENTALVR942 Dose 1
VR942 Dose 2
EXPERIMENTALVR942 Dose 2
VR942 Dose 3
EXPERIMENTALVR942 Dose 3
VR942 Dose 4
EXPERIMENTALVR942 Dose 4
VR942 Dose 5
EXPERIMENTALVR942 Dose 5
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Willingness to give written consent to have data entered into The Over volunteering Prevention System.
- Healthy subjects with FEV1 and FVC of at least 80% of the predicted value at the screening visit
- 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
You may not qualify if:
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vectura Limitedlead
- UCB Pharmacollaborator
Study Sites (1)
Vectura Study Site
London, United Kingdom
Related Publications (1)
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.
PMID: 30146344DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 17, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2016
Last Updated
December 21, 2016
Record last verified: 2016-12