Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
Status: | Completed |
---|---|
Conditions: | Allergy, Allergy |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/1/2014 |
Start Date: | August 2013 |
End Date: | May 2014 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrials@regeneron.com |
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.
ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult
subjects.
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/ exclusion
criteria are listed.
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