Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects

Study Overview
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Brief Summary
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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
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Allergy

Intervention / Treatment
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* Drug: REGN1908-1909
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Dose 1 of REGN1908-1909 or placebo | Drug: REGN1908-1909<br> <br> Other: placebo<br> <br> |
| Experimental: Cohort 2<br>Dose 2 of REGN1908-1909 or placebo | Drug: REGN1908-1909<br> <br> Other: placebo<br> <br> |
| Experimental: Cohort 3<br>Dose 3 of REGN1908-1909 or placebo | Drug: REGN1908-1909<br> <br> Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study). | day 1 to day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration | The secondary endpoint is serum concentrations of REGN1908-1909 over time. | day 1 to day 113 |