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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: Completed Phase 1 study of Enteritis Caused by Radiation (Disorder), sponsored by Theriva Biologics.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Analysis of SYN-020 level present in blood
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 |
What the finished NCT04815993 record still lists
NCT04815993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04815993's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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