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RG1671

Phase 1

Asthma | Small molecule | Respiratory |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

RG1671 · 1 trial · 1 indication

Phase 1 1
NCT00517816A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.Asthma
COMPLETED43 Analytics
PHASE1COMPLETED
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Pharmacodynamic biomarker sampling; skin prick test.
At intervals during study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -
7EXPERIMENTAL -
8EXPERIMENTAL -

Interventions

NameTypeDescription
RG1671DRUGAdministered iv at escalating doses (with a starting dose of 0.0015mg)
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites8

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...

Countries:United States
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Frequently asked questions about RG1671

What is RG1671 used for?

RG1671 is an investigational small molecule being developed for the treatment of asthma. It is currently in clinical development, with a Phase 1 study completed in patients with mild intermittent asymptomatic asthma. The drug is not yet approved and remains under investigation for this respiratory condition.

Who makes RG1671?

RG1671 is being developed by Roche Holding AG, a multinational pharmaceutical company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of RG1671 in patients with asthma.

What phase is RG1671 in?

RG1671 is in Phase 1 of clinical development. A Phase 1 single ascending dose study has been completed in patients with mild intermittent asymptomatic asthma. The drug is still in the early stages of clinical testing and has not been approved by regulatory authorities.

What clinical trials is RG1671 in?

RG1671 has one completed clinical trial, identified as NCT00517816. This was a Phase 1 single ascending dose study conducted in the United States, enrolling 43 patients with mild intermittent asymptomatic asthma. The trial was randomized, double-blind, and controlled, with participants aged 18 years and older.

Is RG1671 FDA approved?

RG1671 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for asthma. The completed Phase 1 trial was designed to assess safety and tolerability, but the drug has not yet received regulatory approval for any use.