An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193

NCT ID: NCT01933763

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-01-31

Brief Summary

Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

REGN1193

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Group B

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.

Group Type: EXPERIMENTAL

REGN1193

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Interventions

REGN1193

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy men and women 18 to 45 years of age (inclusive)

2. Body mass index 18.0 to 30.0 kg/m^2 (inclusive)

3. Normal standard 12-lead ECG

4. Willing and able to comply with clinic visits and study-related procedures

5. Provide signed informed consent

6. 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

1. Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study

2. History of drug or alcohol abuse within a year prior to the screening visit

3. Current regular smoking, or a history of smoking greater than ½ pack

4. 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)

5. 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

6. 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

7. Hospitalization for any reason within 60 days of screening

8. History or presence of malignancy (including carcinoma in situ) prior to the screening visit

9. 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

10. Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Dallas, Texas, United States

Countries

United States

Other Identifiers

R1193-HV-1219

Identifier Type: -

Identifier Source: org_study_id