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

NCT ID: NCT02127801

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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The purposes of this study are to assess the efficacy, safety and tolerability of a single dose of REGN1908-1909 in allergic adult participants, to collect information about how much REGN1908-1909 is in blood over time and to collect information about how the body reacts to REGN1908-1909.

Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Participants in group A will receive REGN1908-1909

Group Type EXPERIMENTAL

REGN1908-1909

Intervention Type DRUG

Group B

Participants in group B will receive placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Interventions

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REGN1908-1909

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Groningen, , Netherlands

Site Status

Auckland, , New Zealand

Site Status

Christchurch, , New Zealand

Site Status

Lund, , Sweden

Site Status

London, , United Kingdom

Site Status

Countries

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Netherlands New Zealand Sweden United Kingdom

References

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Shamji MH, Singh I, Layhadi JA, Ito C, Karamani A, Kouser L, Sharif H, Tang J, Handijiev S, Parkin RV, Durham SR, Kostic A, Orengo JM, DeVeaux M, Kamal M, Stahl N, Yancopoulos GD, Wang CQ, Radin AR. Passive Prophylactic Administration with a Single Dose of Anti-Fel d 1 Monoclonal Antibodies REGN1908-1909 in Cat Allergen-induced Allergic Rhinitis: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Jul 1;204(1):23-33. doi: 10.1164/rccm.202011-4107OC.

Reference Type DERIVED
PMID: 33651675 (View on PubMed)

Other Identifiers

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U1111-1155-2258

Identifier Type: OTHER

Identifier Source: secondary_id

2013-004950-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R1908-1909-ALG-1325

Identifier Type: -

Identifier Source: org_study_id