Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers
Public ClinicalTrials.gov record NCT01197391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study of the Safety, Tolerability and Bioeffect of Subcutaneous REGN 728 in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will test the safety and tolerability (how the body reacts to the drug) of REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by subcutaneous injection (under the skin) at the 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, blood and urine samples will be collected at some or all visits.
Study identification
- NCT ID
- NCT01197391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
- Last update posted
- Nov 11, 2012
2010 – 2012
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Miramar | Florida | — | — |
| Not listed | Overland Park | Kansas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01197391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 11, 2012 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01197391 live on ClinicalTrials.gov.