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

Phase 1

Completed

• Conditions: Allergy
• Interventions: Drug: REGN1908-1909; Other: placebo

• Registration Number: NCT01922661
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-09
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3	REGN1908-1909	Dose 3 of REGN1908-1909 or placebo
Cohort 3	placebo	Dose 3 of REGN1908-1909 or placebo
Cohort 1	REGN1908-1909	Dose 1 of REGN1908-1909 or placebo
Cohort 1	placebo	Dose 1 of REGN1908-1909 or placebo
Cohort 2	REGN1908-1909	Dose 2 of REGN1908-1909 or placebo
Cohort 2	placebo	Dose 2 of REGN1908-1909 or placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum concentration	day 1 to day 113	The secondary endpoint is serum concentrations of REGN1908-1909 over time.