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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR942 Dose 1 | Experimental | VR942 Dose 1 |
|
| VR942 Dose 2 | Experimental | VR942 Dose 2 |
|
| VR942 Dose 3 | Experimental | VR942 Dose 3 |
|
| VR942 Dose 4 | Experimental | VR942 Dose 4 |
|
| VR942 Dose 5 | Experimental | VR942 Dose 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR942 delivered via a Vectura Dry Powder Inhaler | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacodynamics of repeat doses of VR942 in mild asthmatics | o Change in biomarker levels | 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): |
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Inclusion Criteria for Part I & 2:
Exclusion Criteria for Part 1 & 2:
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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vectura Study Site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30146344 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo delivered via a Vectura Dry Powder Inhaler | Drug |
|
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)
| 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 | o Examination of a sample of used blisters and inhalers will be conducted | 28 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |