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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517816

Enrollment

Registered

2007-08-17

Start date

2007-10-31

Completion date

2009-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGRG1671

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, vital signs, ECG.	Throughout study
Serum concentration of R1671, and serum pharmacokinetic parameters.	Throughout study

Secondary

Measure	Time frame
Pharmacodynamic biomarker sampling; skin prick test.	At intervals during study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026