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

Allergy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922661
• Other study ID #: R1908-HV-1240
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2013
• Last updated: June 9, 2014
• Start date: August 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• REGN1908-1909

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Serum concentration	The secondary endpoint is serum concentrations of REGN1908-1909 over time.	day 1 to day 113	No