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NCT03516487 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria
A Phase 1 study, sponsored by Synlogic.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT03516487: Completed Phase 1 study, sponsored by Synlogic.
NCT03516487 is a Phase 1 study that has completed, run by Synlogic. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03516487, a Phase 1 study, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1618 in healthy volunteers (HV) and subjects diagnosed with phenylketonuria (PKU), a rare inherited metabolic disorder that occurs in people who are missing an enzyme that the body needs to use phenylalanine (Phe). Eligible subjects receive investigational product (IP) in the clinic 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 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, electrocardiograms, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emerg
Interventions
- DRUG Placebo
- DRUG SYNB1618
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 1 |
What the finished NCT03516487 record still lists
NCT03516487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03516487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03516487 about?
NCT03516487 is a clinical study titled "Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria". This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1618 in healthy volunteers (HV) and subjects diagnosed with phenylketonuria (PKU), a rare inherited metabolic disorder that occurs in people who are missi...
What is the current status of trial NCT03516487?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2018-04-17. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT03516487?
The interventions under investigation include: Placebo (DRUG), SYNB1618 (DRUG).
Who is sponsoring clinical trial NCT03516487?
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 NCT03516487's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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