Clinical trial NCT02958436: A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Pharmacokinetics
REGN3500
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2016-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females


Eligibility criteria: Inclusion Criteria:

* Body Mass Index\</= 33 kg/m2
* In good health based on medical history, physical examination, vital signs, and laboratory testing
* Normal electrocardiogram (ECG) and blood pressure
* Able to comply with clinic visits and study-related procedures
* Able to sign an informed consent

Exclusion Criteria:

* Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
* Current smoker or recent history (within 3 months)
* History of tuberculosis, HIV, or hepatic disease
* Known sensitivity to doxycycline or other ingredients of study drug
* History of multiple/severe allergies
* Pregnant or breastfeeding women, or not currently using adequate contraception
* Participation in another investigational drug study within 4 weeks

Primary outcomes:
measure: The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
timeFrame: Up to 293 days after dosing
Secondary outcomes:
measure: Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500
timeFrame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
measure: Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500
timeFrame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
measure: Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500
timeFrame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Site 1
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.