Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Allergy
In brief
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.
Key facts
- Study ID
- NCT01922661
- Run by
- Regeneron Pharmaceuticals
- People needed
- 24
- Starts
- 2013-08-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2014-06-10
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Study site — Overland Park, Kansas, United States
- Study site — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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