REGN5713-5714-5715
DrugPart A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
NCT Number: NCT03969849
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Regeneron Study Site, Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply.
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 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Vital signs include blood pressure, heart rate, body temperature, and respiratory rate
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
The limited physical examination will include assessment of heart, lungs, abdomen, peripheral pulses, and skin
Time frame: Up to 16 Weeks
Hematology, chemistry, urinalysis and pregnancy testing samples will be analyzed
Time frame: Up to 16 Weeks
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
Time frame: Up to 16 Weeks
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
Time frame: Up to 16 Weeks
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.
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. PEF is the maximum speed of expiration.
Time frame: Up to 16 Weeks
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.
Time frame: Up to 16 Weeks
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.
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: Up to 16 Weeks
Time frame: At day 8, 29 and 57
Time frame: At day 8, 29 and 57
Time frame: At day 8, 29 and 57
Time frame: At day 8, 29 and 57
Regeneron Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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