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

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517816
• Other study ID #: PP21029
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2007
• Last updated: November 1, 2016
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters, vital signs, ECG.		Throughout study	No
Primary	Serum concentration of R1671, and serum pharmacokinetic parameters.		Throughout study	No
Secondary	Pharmacodynamic biomarker sampling; skin prick test.		At intervals during study	No