NCT Number: NCT01922661
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
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.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Overland Park, Kansas, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
OtherPrimary outcomes
-
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).
Secondary outcomes
-
Serum concentration
Time frame: day 1 to day 113
The secondary endpoint is serum concentrations of REGN1908-1909 over time.
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Aug 14, 2013
- Registry last updated
- Jun 10, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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