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NCT04984525 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
A Phase 1 study of Healthy, sponsored by Synlogic.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT04984525: Completed Phase 1 study of Healthy, sponsored by Synlogic.
NCT04984525 is a Phase 1 study of Healthy that has completed, run by Synlogic. The registered enrollment target is 106 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04984525, a Phase 1 study of Healthy, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.
Primary Outcome
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after th
Conditions Studied
Interventions
- DRUG SYNB1934
- DRUG SYNB1618
Study Locations (1)
North Carolina
- High Point Clinical Trials Center - High Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2021-12-10 |
| Phase | Phase 1 |
What the finished NCT04984525 record still lists
NCT04984525 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which SYNB1934 is the first listed.
NCT04984525 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04984525 about?
NCT04984525 is a clinical study titled "Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers". This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP adminis...
What is the current status of trial NCT04984525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2021-07-02. Estimated completion is 2021-12-10.
What conditions does trial NCT04984525 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04984525?
The interventions under investigation include: SYNB1934 (DRUG), SYNB1618 (DRUG).
Who is sponsoring clinical trial NCT04984525?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04984525 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04984525's enrollment target sits among peer trials
106 208th of 1090 higher than 882 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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