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

NCT01933763 | Completed Phase 1

• 1 other identifier: R1193-HV-1219
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Serum concentration

  day 1 to day 106

Study Arms (2)

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

Interventions

REGN1193 DRUG

Group A; Group B

Placebo OTHER

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Interventions

crotedumab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

US (1)