NCT04629976

Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B

Randomized, Open-Label, Active Comparator, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Hepatitis B Virus (HBV) Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic HBV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Nucorion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study evaluating multiple doses of NCO-48 Fumarate versus tenofovir alafenamide (TAF).

Detailed description

This is a randomized, open-label, active comparator, multiple oral dose study to evaluate the safety, tolerability, pharmacokinetics, and anti-hepatitis B virus (HBV) activity of NCO-48 Fumarate in treatment-naive adults with chronic HBV infection. This study will evaluate the safety, viral kinetics, and antiviral activity of 2 different doses of NCO-48 Fumarate over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of NCO-48 Fumarate versus 25 mg tenofovir alafenamide (TAF) over 28 days of therapy.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	NCO-48 Fumarate 4 mg	2 x 2mg NCO-48 Fumarate over 28 days of therapy
DRUG	NCO-48 Fumarate 20 mg	2 x 10 mg NCO-48 Fumarate over 28 days of therapy
DRUG	Tenofovir Alafenamide 25 mg	25 mg over 28 days of therapy

Timeline

• Start date: 2021-01-12
• Primary completion: 2022-09-30
• Completion: 2022-12-28
• First posted: 2020-11-16
• Last updated: 2023-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study