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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Other: placebo; Drug: REGN1908-1909

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922661

R1908-HV-1240

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Dose 1 of REGN1908-1909 or placebo

Treatment:

Other: placebo

Drug: REGN1908-1909

Cohort 2

Experimental group

Description:

Dose 2 of REGN1908-1909 or placebo

Treatment:

Other: placebo

Drug: REGN1908-1909

Cohort 3

Experimental group

Description:

Dose 3 of REGN1908-1909 or placebo

Treatment:

Other: placebo

Drug: REGN1908-1909