An Ascending Single-Dose Study of the Safety, Tolerabilit... | NCT01933763

NCT01933763

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Participants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo.	Drug: REGN1193 Other: Placebo
Group B	Experimental	Participants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo.	Drug: REGN1193 Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
REGN1193	Drug		Group A Group B
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of TEAEs	The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.	day 1 to day 106

Measure	Description	Time Frame
Serum concentration	Serum concentrations of REGN1193 over time	day 1 to day 106

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women 18 to 45 years of age (inclusive)
Body mass index 18.0 to 30.0 kg/m^2 (inclusive)
Normal standard 12-lead ECG
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent
For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during and for up to 3 months after participation in the study.

Exclusion Criteria:

Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
History of drug or alcohol abuse within a year prior to the screening visit
Current regular smoking, or a history of smoking greater than ½ pack
Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this study
Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
Hospitalization for any reason within 60 days of screening
History or presence of malignancy (including carcinoma in situ) prior to the screening visit
Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).