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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from baseline in abbreviated physical examination

Timeframe: Days 1-2

Changes from baseline in clinical safety laboratory values

Timeframe: From Day 2 up to Day 121

Changes from baseline in Electrocardiogram (ECG) parameters

Timeframe: 15 mins after infusion

Changes from baseline in Electrocardiogram (ECG) parameters

Timeframe: 24 hrs after infusion

Changes from baseline in symptom-directed physical examination

Timeframe: From Day 1 up to Day 121

Changes from baseline in vital signs

Timeframe: From Day 1 up to Day 121

The incidence of Adverse Events

Timeframe: From Day 1 up to Day 121

Trial details

NCT IDNCT03301090

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-01-19

View on ClinicalTrials.gov More Corona Virus Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes from baseline in abbreviated physical examination

Timeframe: Days 1-2

Changes from baseline in clinical safety laboratory values

Timeframe: From Day 2 up to Day 121

Changes from baseline in Electrocardiogram (ECG) parameters

Timeframe: 15 mins after infusion

Changes from baseline in Electrocardiogram (ECG) parameters

Timeframe: 24 hrs after infusion

Changes from baseline in symptom-directed physical examination

Timeframe: From Day 1 up to Day 121

Changes from baseline in vital signs

Timeframe: From Day 1 up to Day 121

The incidence of Adverse Events

Timeframe: From Day 1 up to Day 121

A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria