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NCT04815993 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Tolerability of SYN-020
A Phase 1 study of Enteritis Caused by Radiation (Disorder), sponsored by Theriva Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04815993 is a Phase 1 study of Enteritis Caused by Radiation (Disorder) that has completed, run by Theriva Biologics. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04815993, a Phase 1 study of Enteritis Caused by Radiation (Disorder), has completed, sponsored by Theriva Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile. For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.
Conditions Studied
Interventions
- DRUG SYN-020 delayed release capsule
Study Locations (1)
Wisconsin
- Spaulding Clinical Research LLC - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04815993
The ClinicalTrials.gov registry entry for NCT04815993 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theriva Biologics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Enteritis Caused by Radiation (Disorder) appearing as the primary indexed condition, and to 1 intervention - of which SYN-020 delayed release capsule is the first listed.
NCT04815993 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04815993 about?
NCT04815993 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of SYN-020". This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to ...
What is the current status of trial NCT04815993?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-03-22. Estimated completion is 2021-09-30.
What conditions does trial NCT04815993 study?
This clinical trial studies the following conditions: Enteritis Caused by Radiation (Disorder).
What interventions are being tested in trial NCT04815993?
The interventions under investigation include: SYN-020 delayed release capsule (DRUG).
Who is sponsoring clinical trial NCT04815993?
This trial is sponsored by Theriva Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04815993 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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