AllergyPhase 1NCT01922661
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
A Phase 1 study testing REGN1908-1909 in people with Allergy, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergy
- What is being tested?
- REGN1908-1909
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to May 2014
- 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
- Healthy men and women between the ages of 18 and 55
- Positive allergen skin prick test
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
- Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
- Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
- Hospitalization for any reason within 60 days prior to the screening visit
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
- Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results
- The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baltimore, Maryland
Study site
Overland Park, Kansas
About this study
The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.
- Conditions
- Allergy
- Being tested
- REGN1908-1909, placebo
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN1908-1909Drug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 of REGN1908-1909 or placebo Receives: Drug: REGN1908-1909; Other: placebo |
| Cohort 2 | Experimental | Dose 2 of REGN1908-1909 or placebo Receives: Drug: REGN1908-1909; Other: placebo |
| Cohort 3 | Experimental | Dose 3 of REGN1908-1909 or placebo Receives: Drug: REGN1908-1909; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).
Measured: day 1 to day 113
Secondary outcomes (1)
Serum concentration
The secondary endpoint is serum concentrations of REGN1908-1909 over time.
Measured: day 1 to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionMay 2014
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 AllergyStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922661
- Sponsor's protocol ID
- R1908-HV-1240
- Status last verified
- Jun 2014
- First submitted
- 2 Aug 2013
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26.
PubMed 34437752
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
- ClinicalTrials.gov ID
- NCT01922661
- Acronym / sponsor ID
- R1908-HV-1240
- Conditions
- Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Aug 2013 (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.
The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN1908-1909, Other: placeboDose 1 of REGN1908-1909 or placebo |
| Cohort 2 | Experimental | Drug: REGN1908-1909, Other: placeboDose 2 of REGN1908-1909 or placebo |
| Cohort 3 | Experimental | Drug: REGN1908-1909, Other: placeboDose 3 of REGN1908-1909 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women between the ages of 18 and 55
- Positive allergen skin prick test
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (7 listed)
- Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
- Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
- Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
- Hospitalization for any reason within 60 days prior to the screening visit
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
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 |
|---|---|---|
| REGN1908-1909 | Drug | Cohort 1, Cohort 2, Cohort 3 |
| placebo | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety
Time frame: day 1 to day 113
The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).
1 secondary outcome
Serum concentration
Time frame: day 1 to day 113
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 10 Jun 2014.
- Derived from this study: PubMed 34437752Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26.
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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 Trial Management study director
Regeneron Pharmaceuticals
2 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 REGN1908-1909 in people with Allergy, run by Regeneron Pharmaceuticals at 2 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 7 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 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Safety (time frame: day 1 to day 113). 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 NCT01922661, 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 10 Jun 2014.