deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 16-arm NCT03516487

Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria (PKU)

A Phase 1/2a, First-in-human, Oral Single and Multiple Dose-escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria to Evaluate Safety, Tolerability, Kinetics, and Pharmacodynamics

Sponsor: Synlogic

Interventions Placebo SYNB1618
Updated 12 times since 2018 Last updated: May 11, 2021 Started: Apr 17, 2018 Primary completion: Jun 21, 2019 Completion: Jun 21, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Healthy and Phenylketonuria, this trial is completed. The trial is conducted by Synlogic and has accumulated 12 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotRecruiting~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshotRecruiting~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshotRecruiting~Feb 2019 – ~Jun 2019 · 4 months · monthly snapshotRecruiting~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshotRecruiting~Aug 2019 – ~Aug 2020 · 12 months · monthly snapshotCompleted~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotCompleted~Jun 2021 – ~Apr 2022 · 10 months · monthly snapshotCompleted~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jun 2021 — Apr 2022 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2021 — Jun 2021 [monthly]

    Completed PHASE1_PHASE2

Show 7 earlier versions
  1. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  2. Aug 2019 — Aug 2020 [monthly]

    Completed PHASE1_PHASE2

    Status: RecruitingCompleted

  3. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  4. Feb 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  5. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jul 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Apr 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Synlogic
Data source: Synlogic

For direct contact, visit the study record on ClinicalTrials.gov .