Allergic RhinitisPhase 1NCT01160861
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
A Phase 1 study testing MEMP1972A in people with Allergic Rhinitis, run by Genentech, Inc..
Trial summary
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- MEMP1972A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2010to Apr 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of allergic rhinitis
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug
Who cannot join
- History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- History of anaphylaxis, hypersensitivity or drug allergies
- Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
- Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
- Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
About this study
Official title: A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.
- Conditions
- Allergic Rhinitis
- Being tested
- MEMP1972A, placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMP1972ADrug
Repeating ascending dose
placeboDrug
Repeating ascending dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MEMP1972A; Drug: placebo |
| B | Experimental | Not described Receives: Drug: MEMP1972A; Drug: placebo |
| C | Experimental | Not described Receives: Drug: MEMP1972A; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Measured: Throughout study or until early discontinuation
Incidence, nature, and severity of adverse events
Measured: Throughout study or until early discontinuation
Secondary outcomes (1)
Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)
Measured: Throughout study or until early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start11 Jul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Harris, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160861
- Sponsor's protocol ID
- MOP4840g
- Status last verified
- Dec 2022
- First submitted
- 9 Jul 2010
- Last updated
- 12 Dec 2022
- Results posted
- No
Publications
Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
PubMed 24990880
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01160861
- Acronym / sponsor ID
- MOP4840g
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Jul 2010 (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 is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEMP1972A, Drug: placebo |
| B | Experimental | Drug: MEMP1972A, Drug: placebo |
| C | Experimental | Drug: MEMP1972A, Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of allergic rhinitis
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug
Key exclusion criteria (5 listed)
- History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- History of anaphylaxis, hypersensitivity or drug allergies
- Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
- Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
- Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
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 |
|---|---|---|
| MEMP1972ARepeating ascending dose | Drug | A, B, C |
| placeboRepeating ascending dose | Drug | A, B, C |
Primary outcome
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Throughout study or until early discontinuation
Incidence, nature, and severity of adverse events
Time frame: Throughout study or until early discontinuation
1 secondary outcome
Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)
Time frame: Throughout study or until early discontinuation
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 12 Dec 2022.
- Derived from this study: PubMed 24990880Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
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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.
Jeffrey Harris, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEMP1972A in people with Allergic Rhinitis, run by Genentech, Inc..
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 3 inclusion and 5 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results (time frame: Throughout study or until early discontinuation). 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?
On the ClinicalTrials.gov record for NCT01160861, which also lists 1 linked publication.
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 12 Dec 2022.