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Completed

NCT Number: NCT00517816

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RG1671

Drug

Administered iv at escalating doses (with a starting dose of 0.0015mg)

Primary outcomes

  1. AEs, laboratory parameters, vital signs, ECG.

    Time frame: Throughout study

  2. Serum concentration of R1671, and serum pharmacokinetic parameters.

    Time frame: Throughout study

Secondary outcomes

  1. Pharmacodynamic biomarker sampling; skin prick test.

    Time frame: At intervals during study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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