NCT02617615

A Trial to Evaluate Safety, Tolerability, PK and Antiviral Activity of MB-110 in Hepatitis C Virus Infected Patients

A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral Doses of MB-110 and to Evaluate the Antiviral Activity in Hepatitis C Virus Infected Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Microbio Co Ltd · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral Doses of MB-110 in Healthy Volunteers and to Evaluate the Antiviral Activity of MB-110 in Hepatitis C Virus Infected Subjects

Detailed description

The present study is divided into 2 parts. Part A is a randomized, double blind, placebo controlled, sequential ascending single and multiple oral doses design to evaluate the safety, tolerability, PK, and food effect of MB-110 in healthy volunteers.Part A will recruit 2 groups (Groups 1 and 2) of 8 healthy volunteers in each group. Within each group, 8 subjects will be randomized 6:2 to receive MB-110 versus placebo.Subjects in Group 1 will receive either 50 mg of MB-110 or placebo under fasted conditions during the first visit (Cohort 1); and either 50 mg of MB-110 or placebo under fed conditions during the second visit (Cohort 3) where food effect will be evaluated. Subjects in Group 2 will receive either 100 mg of MB-110 or placebo under fasted condition during the first visit (Cohort 2); or 200 mg of MB-110 or placebo under fasted condition during the second visit (Cohort 4). In Cohort 5, 8 subjects will be selected from Group 1, Group 2, or new recruitment if the washout time is insufficient from the previous cohort. Subjects in Cohort 5 will be randomized 6:2 to receive MB-110 at dose of 200 mg or placebo once daily for 5 consecutive days. Part B is a randomized, double-blind, placebo-controlled, multiple ascending oral dose design to evaluate the safety, tolerability, PK, and antiviral activity of MB-110 in subjects infected with Hepatitis C virus genotype 1b, 2a, and 3a.Part B will recruit 3 cohorts (Cohorts 6, 7, and 8) of treatment-naïve HCV infected subjects in each cohort. In Cohort 6, 12 subjects infected with Hepatitis C virus genotype 1b will be randomized 5:5:2 to receive two dose levels of MB-110 or placebo once daily for 3 consecutive days. In Cohort 7, 6 subjects infected with Hepatitis C virus genotype 2a will be randomized 5:1 to receive MB-110 or placebo once daily for 3 consecutive days. In Cohort 8, 6 subjects infected with Hepatitis C virus genotype 3a will be randomized 5:1 to receive MB-110 or placebo once daily for 3 consecutive days.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	MB-110	MB-110 is a novel, potent, and selective HCV inhibitor against the NS5A protein. In the preclinical studies, MB-110 demonstrated picomolar EC50s towards various genotypes and favorable pharmacokinetic properties to support the once daily dosing regimen.
DRUG	Placebo	It will be identical in appearance and similar in weight to the MB-110 hard-gel capsule.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-12-01
• Last updated: 2017-04-05

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study