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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933763
• Other study ID #: R1193-HV-1219
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2013
• Last updated: March 11, 2015
• Start date: August 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1193

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Serum concentration	Serum concentrations of REGN1193 over time	day 1 to day 106	No