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NCT03063736 · ClinicalTrials.gov registry record · Early Phase 1
Entolimod, an Adjuvant for Vaccine Augmentation
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT03063736 is a Early Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants.
The verdict
NCT03063736, a Early Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this pilot study to evaluate the safety of low dose Entolimod in normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or without entolimod. Subjects will be randomized to: Td alone (n=15) and Td+ entolimod (n=25). The investigators expect that Td + entolimod will double the anti-TT and anti-diphtheria AB levels over Td alone.
Interventions
- DRUG Entolimod
- BIOLOGICAL Td Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2019-12-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03063736
The ClinicalTrials.gov registry entry for NCT03063736 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Entolimod is the first listed.
NCT03063736 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03063736 about?
NCT03063736 is a clinical study titled "Entolimod, an Adjuvant for Vaccine Augmentation". The primary objective of this pilot study to evaluate the safety of low dose Entolimod in normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or without entolimod. Subjects wi...
What is the current status of trial NCT03063736?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2017-12-08. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03063736?
The interventions under investigation include: Entolimod (DRUG), Td Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03063736?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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