Allergy
Conditions
Brief 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.
Interventions
DRUGREGN1908-1909
OTHERplacebo
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy men and women between the ages of 18 and 55 2. Positive allergen skin prick test 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent
Exclusion criteria
1. Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit 2. Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination 3. 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 4. Hospitalization for any reason within 60 days prior to the screening visit 5. 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 6. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration | day 1 to day 113 | The secondary endpoint is serum concentrations of REGN1908-1909 over time. |
Countries
United States
Outcome results
None listed