- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02121080
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States
-
-
Indiana
-
Evansville, Indiana, United States
-
-
Texas
-
Dallas, Texas, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A healthy man or woman aged 18 to 60 years
- Body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Exclusion Criteria:
- Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT], total bilirubin [unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin]) that is >1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
- Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
- Hospitalization for any reason within 60 days of the screening visit
- History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
- History of autoimmune disease
- History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
- History of drug or alcohol abuse within 1 year prior to the screening visit
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
- Pregnant or breastfeeding woman
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Contraception is not required for women with documented hysterectomy or tubal ligation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Dosing regimen 1
|
|
Experimental: Cohort 2
Dosing regimen 2
|
|
Experimental: Cohort 3
Dosing regimen 3
|
|
Experimental: Cohort 4
Dosing regimen 4
|
|
Experimental: Cohort 5
Dosing regimen 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
Time Frame: from day 1 up to week 20 (EOS)
|
from day 1 up to week 20 (EOS)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum concentration
Time Frame: from day 1 over time up to week 20
|
Serum concentration of REGN2222 over time up to week 20
|
from day 1 over time up to week 20
|
Presence or absence of antibodies
Time Frame: from day 1 over time up to week 20
|
The presence or absence of antibodies against REGN2222 over time up to week 20
|
from day 1 over time up to week 20
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R2222-HV-1326
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States