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

NCT01922661 | Completed Phase 1

• 1 other identifier: R1908-HV-1240
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Serum concentration

  day 1 to day 113

Study Arms (3)

Cohort 1

EXPERIMENTAL

Dose 1 of REGN1908-1909 or placebo

Drug: REGN1908-1909; Other: placebo

Cohort 2

EXPERIMENTAL

Dose 2 of REGN1908-1909 or placebo

Drug: REGN1908-1909; Other: placebo

Cohort 3

EXPERIMENTAL

Dose 3 of REGN1908-1909 or placebo

Drug: REGN1908-1909; Other: placebo

Interventions

REGN1908-1909 DRUG

Cohort 1; Cohort 2; Cohort 3

placebo OTHER

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Related Publications (1)

• Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26.

  PMID: 34437752 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

US (2)