A Single Ascending Dose Study of R1671 in Patients With M... | NCT00517816

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

NCT00517816

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

43Actual

Phase

Phase 1

Conditions

Asthma

Interventions

RG1671

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Aug 16, 2007

First Submission Date that Met QC Criteria

Aug 16, 2007

First Posted Date

Aug 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: RG1671
2	Experimental	Drug: RG1671
3	Experimental	Drug: RG1671
4	Experimental	Drug: RG1671
5	Experimental	Drug: RG1671
6	Experimental	Drug: RG1671
7	Experimental	Drug: RG1671
8	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RG1671	Drug	Administered iv at escalating doses (with a starting dose of 0.0015mg)	1 2 3 4 5 6

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas	72204	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided