Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by an injection under the skin at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

NCT01026597

Healthy

COMPLETED PHASE1

Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers

NCT01197391

Healthy

COMPLETED PHASE1

A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)

NCT01507402

Healthy Volunteers

COMPLETED PHASE1

Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)

NCT01720576

Healthy Volunteers

COMPLETED PHASE1

Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers

NCT01015027

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Dose 1 versus placebo

Group Type EXPERIMENTAL

REGN727

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Placebo

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Cohort 2

Dose 2 versus placebo

Group Type EXPERIMENTAL

REGN727

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Placebo

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Cohort 3

Dose 3 versus placebo

Group Type EXPERIMENTAL

REGN727

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Placebo

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Cohort 4

Dose 4 versus placebo

Group Type EXPERIMENTAL

REGN727

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Placebo

Intervention Type DRUG

4 cohorts (dose 1, 2, 3, 4)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REGN727

4 cohorts (dose 1, 2, 3, 4)

Intervention Type DRUG

Placebo

4 cohorts (dose 1, 2, 3, 4)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Pregnant or breast-feeding females.
* 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 would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within previous 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes