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

NCT04909723 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-05-17

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Enteric Hyperoxaluria

Interventions

COMBINATION_PRODUCT

NOV-001

NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.

BIOLOGICAL

NB1000S

A recombinant live biotherapeutic product.

DRUG

NB2000P

A botanically derived polysaccharide.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Novome Biotechnologies Inc

    lead INDUSTRY

Principal Investigators

  • Lachy McLean, MB ChB, PhD · Novome Biotechnologies Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-11-30
Completion
2023-04-06
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909723 on ClinicalTrials.gov