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NCT02788188 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
A Phase 1 study of Middle East Respiratory Syndrome Coronavirus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT02788188 is a Phase 1 study of Middle East Respiratory Syndrome Coronavirus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 38 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02788188, a Phase 1 study of Middle East Respiratory Syndrome Coronavirus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory virus. People often get MERS through close contact with an infected person. Scientists are worried that MERS may spread and cause more infections. There are no vaccines or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid part of cow blood. Objective: To evaluate the safety and tolerability of SAB-301 in healthy adults. Eligibility: Healthy people ages 18 60 who: Do not have chronic medical problems Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal allergy meds and oral contraception) Do not have allergies to beef products Agree to use two forms of contraception while on study (both men and women) Design: Participants will be screened with: Medical history Physical examination Blood and urine tests Participants will have a return visit. They will have a physical exam and blood tests. They will be randomly assigned to receive either SAB-301 or a placebo which is given by infusion through an arm vein over 1 3 hours. They will be monitored at the clinic for 6 hours after the infusion. They will have additional blood draws. Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each visit they will be evaluated and have blood and urine tests.
Conditions Studied
Interventions
- BIOLOGICAL SAB-301
- OTHER Normal (9%) Saline
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-05-28 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02788188
The ClinicalTrials.gov registry entry for NCT02788188 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Middle East Respiratory Syndrome Coronavirus appearing as the primary indexed condition, and to 2 interventions - of which SAB-301 is the first listed.
NCT02788188 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02788188 about?
NCT02788188 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults". Background: Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory virus. People often get MERS through close contact with an infected person. Scientists are worried that MERS may spread and cause more infections. There are no vaccines or treatments...
What is the current status of trial NCT02788188?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2016-05-28. Estimated completion is 2018-04-30.
What conditions does trial NCT02788188 study?
This clinical trial studies the following conditions: Middle East Respiratory Syndrome Coronavirus.
What interventions are being tested in trial NCT02788188?
The interventions under investigation include: SAB-301 (BIOLOGICAL), Normal (9%) Saline (OTHER).
Who is sponsoring clinical trial NCT02788188?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02788188 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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