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

Roche

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: RG1671

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517816

PP21029

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 8 patient groups

1

Experimental group

Treatment:

Drug: RG1671

2

Experimental group

Treatment:

Drug: RG1671

3

Experimental group

Treatment:

Drug: RG1671

4

Experimental group

Treatment:

Drug: RG1671

5

Experimental group

Treatment:

Drug: RG1671

6

Experimental group

Treatment:

Drug: RG1671

7

Experimental group

Treatment:

Drug: RG1671

8

Experimental group

Treatment:

Drug: RG1671