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Corona Virus InfectionPhase 1NCT03301090

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

A Phase 1 study testing REGN3048 and REGN3051 in people with Corona Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Corona Virus Infection
What is being tested?
REGN3048 and REGN3051
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
12 Feb 2018to 19 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All must be answered yes for the subject to be eligible for study participation
  • 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)
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  • 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
  • Screening laboratory tests, are in the normal reference range with acceptable exceptions
  • Notes:
  • If urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose and protein.
  • Menstruating females failing inclusion criteria due to a positive blood on urine test (dipstick or microscopic urinalysis) may be retested following cessation of menses. Do not exclude subjects with <5 RBC/HPF.
  • Other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to collection or laboratory error may be repeated once.
  • Vital signs are within the acceptable range
  • Has adequate venous access for the infusion and blood collection
  • The urine drug screen is negative
  • Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study
  • Available for follow-up for the duration of the study

Who cannot join

  • Subjects meeting any of the following exclusion criteria are not eligible for participation.
  • All must be answered no for the subject to be eligible for study participation
  • 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.
  • Note: Chronic medical conditions include diabetes; Asthma requiring use of medication in the year before screening; Autoimmune disorder such as lupus, Wegener's, rheumatoid arthritis, thyroid disease; Coronary artery disease; Chronic hypertension; History of malignancy except low-grade (squamous and basal cell) skin cancer thought to be cured; chronic renal, hepatic, pulmonary, or endocrine disease; myopathy, and neuropathy
  • History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
  • Note: Severe allergic reaction is defined as any of the following: anaphylaxis, urticaria, or angioedema
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  • 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)
  • Known allergic reactions to doxycycline or to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
  • Treatment with another investigational product within 30 days of dosing, including a drug, vaccine, biologic, device or blood product
  • Treatment with a monoclonal antibody at any time in the past or planned use during the study period
  • Receipt of antibody* or blood transfusion within 6 months of dosing or within 5 half-lives of the specific product given
  • Note: Tetanus Immune Globulin [TIG], Varicella-Zoster Immune Globulin [VZIG], Intravenous Immunoglobulin [IVIG], Intramuscular [IM] gamma globulin
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  • Use of H1 antihistamines or beta-blockers within 5 days of dosing
  • Use of any prohibited medication within 30 days prior to study dosing or planned use during the study period Note: Prohibited medications include immunosuppressives (except nonsteroidal antiinflammatory drugs [NSAIDS]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents; any licensed biologic including monoclonal antibody or vaccine with the exception of licensed influenza vaccine during the flu season, which is allowed 7 days prior to dosing or 7 days after dosing
  • Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
  • Plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period Note: Includes trials that have a study intervention such as a drug, biologic, or device
  • Is a study site employee or staff who are paid entirely or partially by the NIAID Office of Clinical Research Resources (OCRR) contract for the DMID-funded trial Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT Global Cypress Clinical Pharmacology Unit

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

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.

Read the detailed description

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. Secondary Objectives: 1) To assess the pharmacokinetic (PK) profiles of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's); 2) To assess the immunogenicity of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's)

Being tested
Placebo, REGN3048, REGN3051
Keywords
Adults, Evaluate, Healthy, Immunogenicity, MERS-CoV, Pharmacokinetics, Phase I, Placebo, REGN MERS, Safety, Tolerability
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Placebo

  • REGN3048Biological

    REGN3048 is a fully monoclonal antibody (mAbs) which binds to the S protein of MERS-CoV.

  • REGN3051Biological

    REGN3051 is a fully human monoclonal antibody (mAb) which binds to the S protein of MERS-CoV. It can reduce virus titers and ameliorate MERS-CoV-induced lung pathology when given post infection.

Study groups in NCT03301090
Study groupRoleWhat they receive
Cohort AExperimentalREGN3048+REGN3051 3 mg/kg (1.5 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051
Cohort BExperimentalREGN3048+REGN3051 10 mg/kg (5 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051
Cohort CExperimentalREGN3048+REGN3051 30 mg/kg (15 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051
Cohort DExperimentalREGN3048+REGN3051 50 mg/kg (25 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051
Cohort EExperimentalREGN3048+REGN3051 100 mg/kg (50 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051
Cohort FExperimentalREGN3048+REGN3051 150 mg/kg (75 mg/kg of each mAb) single infusion IV, n=6; placebo IV, n=2
Receives: Other: Placebo; Biological: REGN3048; Biological: REGN3051

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline in abbreviated physical examination

    Measured: Days 1-2

  2. Changes from baseline in clinical safety laboratory values

    Measured: From Day 2 up to Day 121

  3. Changes from baseline in Electrocardiogram (ECG) parameters

    Measured: 15 mins after infusion

  4. Changes from baseline in Electrocardiogram (ECG) parameters

    Measured: 24 hrs after infusion

  5. Changes from baseline in symptom-directed physical examination

    Measured: From Day 1 up to Day 121

  6. Changes from baseline in vital signs

    Measured: From Day 1 up to Day 121

  7. The incidence of Adverse Events

    Measured: From Day 1 up to Day 121

  8. The incidence of treatment-emergent Serious Adverse Events

    Measured: From Day 1 up to Day 121

  9. The severity of Adverse Events assessed by toxicity grading criteria

    Measured: From Day 1 up to Day 121

  10. The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria

    Measured: From Day 1 up to Day 121

  11. The type of treatment-emergent Serious Adverse Events

    Measured: From Day 1 up to Day 121

Secondary outcomes (18)

  1. AUC for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  2. AUC for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  3. AUC(0-infinity) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  4. AUC(0-infinity) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  5. CL for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  6. CL for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  7. CMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  8. CMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  9. K(e) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  10. K(e) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  11. t(1/2) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  12. t(1/2) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  13. The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

    Measured: Day 121

  14. The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

    Measured: Day 57

  15. TMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  16. TMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  17. V(ss) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

  18. V(ss) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Measured: From Day 1 up to Day 121

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2017
  2. Study start12 Feb 2018
  3. Primary completion19 Jan 2019
  4. Study completion19 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301090
Sponsor's protocol ID
15-0109
Other IDs
HHSN272201500005I
Status last verified
22 Sep 2017
First submitted
14 Sep 2017
Last updated
1 Feb 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing REGN3048 and REGN3051 in people with Corona Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in abbreviated physical examination (time frame: Days 1-2). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03301090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.

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