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REGN5713-5714-5715 · 1 trial · 2 indications
Vital signs include blood pressure, heart rate, body temperature, and respiratory rate
The limited physical examination will include assessment of heart, lungs, abdomen, peripheral pulses, and skin
Hematology, chemistry, urinalysis and pregnancy testing samples will be analyzed
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FVC is the total amount of air exhaled during the forced expiratory volume (FEV) test
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV in 1 second (FEV1) must be ≥80% predicted to perform the NAC. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV1 must be ≥80% predicted to perform the NAC.
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. PEF is the maximum speed of expiration.
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. Forced expiratory flow during the mid (25 - 75%) portion of the FVC.
Performed prior to every NAC procedure in all participants. A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control. Participants must have ACT ≥20 before undergoing the NAC.
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort 1 | EXPERIMENTAL | Part A: Cohort 1 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 2 | EXPERIMENTAL | Part A: Cohort 2 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 3 | EXPERIMENTAL | Part A: Cohort 3 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 4 | EXPERIMENTAL | Part A: Cohort 4 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part B | EXPERIMENTAL | Part B: Randomized 1:1 will receive REGN5713-5714-5715 or matching placebo in Healthy Participants with birch pollen allergy |
| Name | Type | Description |
|---|---|---|
| REGN5713-5714-5715 | 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 | 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 |
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...
REGN5713-5714-5715 is an investigational small molecule drug being developed by Regeneron Pharmaceuticals for birch pollen allergy. It is in Phase 1 clinical development and has been studied in healthy adult participants. It is not approved for any use.
REGN5713-5714-5715 is being developed for birch pollen allergy, a respiratory condition. The only completed clinical study enrolled healthy adult volunteers, including participants with birch pollen allergy, to assess safety, tolerability, pharmacokinetic, and pharmacodynamic effects after a single dose.
Regeneron Pharmaceuticals, Inc. is developing REGN5713-5714-5715. Regeneron trades on the Nasdaq under the ticker symbol REGN. The company is the sponsor of the clinical program for this investigational small molecule candidate.
REGN5713-5714-5715 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for birch pollen allergy or any other indication.
REGN5713-5714-5715 has been studied in one completed Phase 1 trial, NCT03969849, titled a study to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of a single dose in healthy adult participants. The trial enrolled 96 participants in Belgium and was randomized, double-blind, and controlled.