drugset
drugset / Trial / NCT04909723

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

NCT04909723 ↗

Phase 1/2 Terminated 153 enrolled Novome Biotechnologies Inc
RandomizedParallel-groupSingle-blindTreatment

Summary

The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers. The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.

Timeline

Start
2021-06-02
Primary completion
2022-11-30
Completion
2023-04-06

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision to discontinue study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject NB1000S Other / unclassified 1e+09 cells —
Subject NB2000P Other / unclassified 0.5 g —
Subject NB2000P Other / unclassified 10 g —

Indications

No indication recorded.