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NCT05462132 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
A Phase 1 study, sponsored by Synlogic.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05462132: Completed Phase 1 study, sponsored by Synlogic.
NCT05462132 is a Phase 1 study that has completed, run by Synlogic. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05462132, a Phase 1 study, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
Primary Outcome
Lab results outside of the central laboratory normal range parameters will be considered abnormal and reviewed for clinical significance and reported as AEs. AEs will be evaluated using the NCI CTCAE v5.0
Interventions
- DRUG SYNB1353
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2022-11-27 |
| Phase | Phase 1 |
What the finished NCT05462132 record still lists
NCT05462132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which SYNB1353 is the first listed.
NCT05462132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05462132 about?
NCT05462132 is a clinical study titled "Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers". This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
What is the current status of trial NCT05462132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-07-07. Estimated completion is 2022-11-27.
What interventions are being tested in trial NCT05462132?
The interventions under investigation include: SYNB1353 (DRUG).
Who is sponsoring clinical trial NCT05462132?
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 NCT05462132's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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