Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety study
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:
- 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.
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: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Little Rock, AR
- Burbank, CA
- Port Orange, FL
- Madisonville, KY
- North Dartmouth, MA
