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NCT03447730 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacodynamics of SYNB1020
A Phase 1 study, sponsored by Synlogic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03447730: Clinical Trial Phase 1 study, sponsored by Synlogic.
NCT03447730 is a Phase 1 study that was terminated before completion, run by Synlogic. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03447730, a Phase 1 study, was terminated before completion, sponsored by Synlogic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This Phase 1b/2a, randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients with hyperammonemia, with dosing of the investigational medicinal product (IMP) administered in an inpatient unit and subsequent outpatient follow-up for SYNB1020 clearance in two study parts.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, as follows: Grade 1 (mild/asymptomatic; no intervention); Grade 2 (moderate; minimal intervention); Grade 3 (severe/medically significant; hospitalization indicated; disabling); Grade 4 (life-threatening; urgent intervention required). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical exa
Interventions
- OTHER Placebo
- DRUG SYNB1020
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2019-07-19 |
| Phase | Phase 1 |
Why NCT03447730 stopped before completion
NCT03447730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03447730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03447730 about?
NCT03447730 is a clinical study titled "Safety, Tolerability and Pharmacodynamics of SYNB1020". This Phase 1b/2a, randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients with hyperammonemia, with dosing of the investigational medicinal product (IMP) administered in an ...
What is the current status of trial NCT03447730?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-03-19. Estimated completion is 2019-07-19.
What interventions are being tested in trial NCT03447730?
The interventions under investigation include: Placebo (OTHER), SYNB1020 (DRUG).
Who is sponsoring clinical trial NCT03447730?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03447730's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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