A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Ant… (NCT03301090) | Clinical Trial Compass
CompletedPhase 1
A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051
United States48 participantsStarted 2018-02-12
Plain-language summary
This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Informed consent understood and signed prior to initiation of any study procedures
✓. Healthy male or healthy, non-pregnant, non-lactating female, meeting eligibility criteria as assessed by the clinicians listed on the FDA Form 1572
✓. Willingness to comply and be available for all protocol procedures including inpatient confinement for about 3 days
✓. Age between 18 and 45 years, inclusive on the day of infusion
✓. Body Mass Index (BMI) of \> or =18.5 and \>or =30 kg/m2 and Weight \> or = 50 kg (110 lbs) and \< or = 100 kg (220 lbs)
✓. In female subject of childbearing potential, a negative serum pregnancy test at screening and negative serum test within 24 hours prior to infusion Note: A woman is considered of childbearing potential unless post-menopausal (\> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy
✓. Females of childbearing potential and males agree to use acceptable contraception for the duration of the study Note: A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) according to the CDC criteria.30. These include progestin implants, intrauterine devices (IUDs), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. Use of methods with higher failure rate (such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms) will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the DMID MM. All males will be required to use a barrier method (condoms) for the duration of the study
What they're measuring
1
Changes from baseline in abbreviated physical examination
Timeframe: Days 1-2
2
Changes from baseline in clinical safety laboratory values
Timeframe: From Day 2 up to Day 121
3
Changes from baseline in Electrocardiogram (ECG) parameters
Timeframe: 15 mins after infusion
4
Changes from baseline in Electrocardiogram (ECG) parameters
Timeframe: 24 hrs after infusion
5
Changes from baseline in symptom-directed physical examination
Timeframe: From Day 1 up to Day 121
6
Changes from baseline in vital signs
Timeframe: From Day 1 up to Day 121
7
The incidence of Adverse Events
Timeframe: From Day 1 up to Day 121
8
The incidence of treatment-emergent Serious Adverse Events
Timeframe: From Day 1 up to Day 121
Trial details
NCT IDNCT03301090
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✓. Screening laboratory tests, are in the normal reference range with acceptable exceptions
Exclusion criteria
✕. History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
✕. History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
✕. A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTcF interval \>450 milliseconds)
✕. Clinically significant abnormal electrocardiogram at screening Note: Clinically significant abnormal ECG results include: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator
✕. Positive serology results for HIV, HBsAg, or HCV antibodies
✕. Febrile illness with temperature \>37.6°C 7 days prior to dosing
✕. Pregnant or breastfeeding
✕. Donated whole blood or blood products within 56 days prior to dosing or plans to donate blood prior to the last scheduled visit in the study (Day 121) Note: Blood products are defined as red blood cells, white blood cells, platelets or plasma)
9
The severity of Adverse Events assessed by toxicity grading criteria
Timeframe: From Day 1 up to Day 121
10
The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria
Timeframe: From Day 1 up to Day 121
11
The type of treatment-emergent Serious Adverse Events