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
Overview
- Phase
- Phase 1
- Intervention
- VR942 delivered via a Vectura Dry Powder Inhaler
- Conditions
- Asthma
- Sponsor
- Vectura Limited
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
VR942 Dose 2
VR942 Dose 2
Intervention: VR942 delivered via a Vectura Dry Powder Inhaler
VR942 Dose 1
VR942 Dose 1
Intervention: VR942 delivered via a Vectura Dry Powder Inhaler
VR942 Dose 1
VR942 Dose 1
Intervention: Placebo delivered via a Vectura Dry Powder Inhaler
VR942 Dose 2
VR942 Dose 2
Intervention: Placebo delivered via a Vectura Dry Powder Inhaler
VR942 Dose 3
VR942 Dose 3
Intervention: VR942 delivered via a Vectura Dry Powder Inhaler
VR942 Dose 3
VR942 Dose 3
Intervention: Placebo delivered via a Vectura Dry Powder Inhaler
VR942 Dose 4
VR942 Dose 4
Intervention: VR942 delivered via a Vectura Dry Powder Inhaler
VR942 Dose 4
VR942 Dose 4
Intervention: Placebo delivered via a Vectura Dry Powder Inhaler
VR942 Dose 5
VR942 Dose 5
Intervention: VR942 delivered via a Vectura Dry Powder Inhaler
VR942 Dose 5
VR942 Dose 5
Intervention: Placebo delivered via a Vectura Dry Powder Inhaler
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)