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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Novome Biotechnologies Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is evaluating the safety, tolerability, pharmacodynamics, and early efficacy of NOV-001. NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide. In Stage 1, NB1000S (or placebo) is administered on the first day of treatment and NB2000P is administered once daily, or as indicated in the adaptive study design. In Stage 2, NB1000S (or placebo) is administered two times per day on the first day of the treatment and NB2000P (or placebo) is administered once daily for 28 days, at doses determined in Stage 1.

Conditions

• Healthy Volunteers
• Enteric Hyperoxaluria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-11-30
• Completion: 2023-04-06
• First posted: 2021-06-02
• Last updated: 2023-05-17

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study