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

A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Subjects

Sponsors

Lead Sponsor: Regeneron Pharmaceuticals

Source Regeneron Pharmaceuticals
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.

Overall Status Completed
Start Date 2019-06-03
Completion Date 2020-03-27
Primary Completion Date 2020-03-27
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs) Up to 16 Weeks
The number of participants with abnormal adverse events (AEs) Up to 16 Weeks
The number of participants with abnormal vital signs Up to 16 Weeks
The number of participants with abnormal 12-lead electrocardiograms (ECGs) Up to 16 Weeks
The number or participants with abnormal physical examinations Up to 16 Weeks
The number of abnormal laboratory examination Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced vital capacity (FVC) litres (L) Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory volume in 1 second (FEV1) Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - FEV1/FVC (%) Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - peak expiratory flow (PEF) Litre/second (L/s) Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory flow 25 to 75 (L/s) Up to 16 Weeks
Part B only - The number of participants with poorly controlled asthma using asthma control test (ACT) Up to 16 Weeks
Secondary Outcome
Measure Time Frame
Total concentration of REGN5713 in serum over time Up to 16 Weeks
Total concentration of REGN5714 in serum over time Up to 16 Weeks
Total concentration of REGN5715 in serum over time Up to 16 Weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN5713 Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5714 Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5715 Up to 16 Weeks
Change in area under the curve (AUC) for TNSS (0 to 1 hour post-peak TNSS) in response to a nasal allergen challenge (NAC) from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo At day 8, 29 and 57
Percent change in AUC for TNSS (0 to 1 hour post-peak TNSS) in response to a NAC from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo At day 8, 29 and 57
Change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo At day 8, 29 and 57
Percent change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo At day 8, 29 and 57
Enrollment 96
Condition
Intervention

Intervention Type: Drug

Intervention Name: REGN5713-5714-5715

Description: 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

Intervention Name: Matching placebo

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

Eligibility

Criteria:

Key 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 Key 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 NOTE: Other protocol defined inclusion/exclusion criteria apply.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Clinical Trial Management Study Director Regeneron Pharmaceuticals
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility:
Regeneron Study Site | Antwerp, Belgium
Regeneron Study Site | Ghent, Belgium
Regeneron Study Site | Leuven, Belgium
Location Countries

Belgium

Verification Date

2020-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Part A: Cohort 1

Type: Experimental

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

Label: Part A: Cohort 2

Type: Experimental

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

Label: Part A: Cohort 3

Type: Experimental

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

Label: Part A: Cohort 4

Type: Experimental

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

Label: Part B

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on REGN5713-5714-5715