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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RG1671

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

AEs, laboratory parameters, vital signs, ECG.

Serum concentration of R1671, and serum pharmacokinetic parameters.

Secondary Outcome Measures

Pharmacodynamic biomarker sampling; skin prick test.

Full Information

NCT ID

NCT00517816

First Posted

August 16, 2007

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00517816

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RG1671

Intervention Description

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

Primary Outcome Measure Information:

Title

AEs, laboratory parameters, vital signs, ECG.

Time Frame

Throughout study

Title

Serum concentration of R1671, and serum pharmacokinetic parameters.

Time Frame

Throughout study

Secondary Outcome Measure Information:

Title

Pharmacodynamic biomarker sampling; skin prick test.

Time Frame

At intervals during study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

City

Morrisville

State/Province

North Carolina

ZIP/Postal Code

27560

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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