Chronic Hepatitis C Clinical Trial
Official title:
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
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
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.
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