AsthmaPhase 1NCT00517816
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
A Phase 1 study testing RG1671 in people with Asthma, run by Hoffmann-La Roche at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- RG1671
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients, 18-50 years of age;
- mild, intermittent, asymptomatic asthma;
- history of asthma for >=6 months;
- non-smokers.
Who cannot join
- females of childbearing potential, or lactating;
- history of immunologically medicated disease;
- systemic antineoplastic or immunomodulatory treatment in past 6 months.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Little Rock, Arkansas, 72204
Study site
Madisonville, Kentucky, 42431
Study site
Morrisville, North Carolina, 27560
Study site
Normal, Illinois, 61761
Study site
North Dartmouth, Massachusetts, 02747
Study site
North Hollywood, California, 91606
Study site
Port Orange, Florida, 32127
Study site
San Antonio, Texas, 78209
About this study
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
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.
- Conditions
- Asthma
- Being tested
- RG1671
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1671Drug
Administered iv at escalating doses (with a starting dose of 0.0015mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RG1671 |
| 2 | Experimental | Not described Receives: Drug: RG1671 |
| 3 | Experimental | Not described Receives: Drug: RG1671 |
| 4 | Experimental | Not described Receives: Drug: RG1671 |
| 5 | Experimental | Not described Receives: Drug: RG1671 |
| 6 | Experimental | Not described Receives: Drug: RG1671 |
| 7 | Experimental | Not described Receives: Drug: RG1671 |
| 8 | Experimental | Not described Receives: Drug: RG1671 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, laboratory parameters, vital signs, ECG.
Measured: Throughout study
Serum concentration of R1671, and serum pharmacokinetic parameters.
Measured: Throughout study
Secondary outcomes (1)
Pharmacodynamic biomarker sampling; skin prick test.
Measured: At intervals during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517816
- Sponsor's protocol ID
- PP21029
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00517816
- Acronym / sponsor ID
- PP21029
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: RG1671 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult patients, 18-50 years of age;
- mild, intermittent, asymptomatic asthma;
- history of asthma for >=6 months;
- non-smokers.
Key exclusion criteria (3 listed)
- females of childbearing potential, or lactating;
- history of immunologically medicated disease;
- systemic antineoplastic or immunomodulatory treatment in past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RG1671Administered iv at escalating doses (with a starting dose of 0.0015mg) | Drug | 1, 2, 3, 4, 5, 6, 7, 8 |
Primary outcome
AEs, laboratory parameters, vital signs, ECG.
Time frame: Throughout study
Serum concentration of R1671, and serum pharmacokinetic parameters.
Time frame: Throughout study
1 secondary outcome
Pharmacodynamic biomarker sampling; skin prick test.
Time frame: At intervals during study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RG1671 in people with Asthma, run by Hoffmann-La Roche at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs, laboratory parameters, vital signs, ECG. (time frame: Throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.