A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.

Study Overview
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Brief Summary
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This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild, intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671, at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in subsequent groups of patients after a satisfactory assessment of the data from the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
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A Randomized, Double-blind, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Pharmacodynamic Biomarkers of an Intravenous Infusion of R1671 in Patients With Mild, Intermittent Asymptomatic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: RG1671


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-50 years of age; mild, intermittent, asymptomatic asthma; history of asthma for >=6 months; non-smokers. Exclusion Criteria: females of childbearing potential, or lactating; history of immunologically medicated disease; systemic antineoplastic or immunomodulatory treatment in past 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 2<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 3<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 4<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 5<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 6<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 7<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|
| Experimental: 8<br> | Drug: RG1671<br>* Administered iv at escalating doses (with a starting dose of 0.0015mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs, ECG. |  | Throughout study | 
| Serum concentration of R1671, and serum pharmacokinetic parameters. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic biomarker sampling; skin prick test. |  | At intervals during study |