Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

NCT ID: NCT03969849

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2020-03-27

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants.

The secondary objectives of the study are:

In Part A and Part B:

• To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults
• To assess the immunogenicity of single dose of REGN5713-5714-5715.

In Part B:

• To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715
• To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

Conditions

Healthy Volunteers; Birch Pollen Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Cohort 1

Part A: Cohort 1 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo

Group Type: EXPERIMENTAL

REGN5713-5714-5715

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Matching placebo

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Part A: Cohort 2

Part A: Cohort 2 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo

Group Type: EXPERIMENTAL

REGN5713-5714-5715

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Matching placebo

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Part A: Cohort 3

Part A: Cohort 3 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo

Group Type: EXPERIMENTAL

REGN5713-5714-5715

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Matching placebo

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Part A: Cohort 4

Part A: Cohort 4 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo

Group Type: EXPERIMENTAL

REGN5713-5714-5715

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Matching placebo

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Part B

Part B: Randomized 1:1 will receive REGN5713-5714-5715 or matching placebo in Healthy Participants with birch pollen allergy

Group Type: EXPERIMENTAL

REGN5713-5714-5715

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Matching placebo

Intervention Type: DRUG

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Interventions

REGN5713-5714-5715

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Intervention Type: DRUG

Matching placebo

Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed prior to study drug dosing
• Participant is in good health based on laboratory safety testing obtained at the screening prior to study drug dosing
• Part B: Has a medical history of birch tree pollen-triggered allergic rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons) based on participant's recall
• Part B: Has positive skin prick test (SPT) with birch tree pollen extract (mean wheal diameter ≥5 mm greater than a negative control) in screening period

Exclusion Criteria

• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confound the results of the study or pose an additional risk to the participant by study participation
• Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by study participation
• Participation in any clinical research study evaluating another investigational drug or therapy within 90 days or at least 5 half-lives (whichever is longer) for an investigational biologic drug, or at least 28 days for other investigational products, or within 6 months for immunotherapy prior to the screening visit of the current trial
• Pregnant or breastfeeding women
• Part B: Receipt of study drug REGN5713-5714-5715 in Part A
• Part B: Significant rhinitis or sinusitis outside of the birch pollen season or due to daily contact with other allergens causing symptoms, that is expected to coincide with the study NAC assessments as assessed by the investigator
• Part B: A clinical history of asthma requiring chronic medication such as regular, inhaled corticosteroids for >6 months per year
• Part B: History of birch allergy immunotherapy (SCIT, sublingual immunotherapy, or oral immunotherapy) in the 5 years prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Study Site

Antwerp, , Belgium

Regeneron Study Site

Ghent, , Belgium

Regeneron Study Site

Leuven, , Belgium

Countries

Belgium

References

Gevaert P, De Craemer J, De Ruyck N, Rottey S, de Hoon J, Hellings PW, Volckaert B, Lesneuck K, Orengo JM, Atanasio A, Kamal MA, Abdallah H, Kamat V, Dingman R, DeVeaux M, Ramesh D, Perlee L, Wang CQ, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study. J Allergy Clin Immunol. 2022 Jan;149(1):189-199. doi: 10.1016/j.jaci.2021.05.039. Epub 2021 Jun 11.

Reference Type: DERIVED

PMID: 34126156 (View on PubMed)

Other Identifiers

2018-004681-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R5713-5714-5715-HV-1857

Identifier Type: -

Identifier Source: org_study_id