Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03969849 | Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants | PHASE1 | COMPLETED | 96 | — | — | Jun 3, 2019 | Mar 27, 2020 | Apr 28, 2020 | 3 | Belgium |
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...