deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 8-arm NCT04909723

Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria

Sponsor: Novome Biotechnologies Inc

Conditions Enteric Hyperoxaluria Healthy Volunteers
Interventions NB1000S NB2000P NOV-001 Placebo
Updated 17 times since 2021 Last updated: May 16, 2023 Started: Jun 2, 2021 Primary completion: Nov 30, 2022 Completion: Apr 6, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision to discontinue study.

A PHASE1/PHASE2 clinical study on Enteric Hyperoxaluria and Healthy Volunteers, this trial is terminated or withdrawn. The trial is conducted by Novome Biotechnologies Inc and has accumulated 17 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~May 2022 · 2 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jun 2023 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

    Status: Active Not Recruiting → Terminated

  5. Apr 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

▶ Show 12 earlier versions

  1. Jan 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  4. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Mar 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Dec 2021 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

    Phase: PHASE1 → PHASE1_PHASE2

  12. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

    First recorded

Jun 2021

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novome Biotechnologies Inc
Data source: Novome Biotechnologies Inc

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

Study Locations

Birmingham, United States , Carmel, United States , Cincinnati, United States , Cleveland, United States , Daytona Beach, United States , Doral, United States , Hanover, United States , Houston, United States , Iowa City, United States , Knoxville, United States and 9 more locations