Trial Information

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

Status: Recruiting

Protocol Number: PP21029

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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

Brief Summary: 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. Target sample size is 64.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety

Study Type:

Condition: Asthma

Intervention Type: Drug

Intervention Name: R1671

Primary Outcome: 1. AEs, laboratory parameters, vital signs, ECG. Time frame: Throughout study 2. Serum concentration of R1671, and serum pharmacokinetic parameters. Time frame: Throughout study

Key Secondary Outcomes: 1. Pharmacodynamic biomarker sampling; skin prick test. Time frame: At intervals during study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 50 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2007

Trial Registration Date: 08/15/2007

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 3:19:17 PM