Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02617615
Status:
UNKNOWN
Last Update Posted:
2017-04-05
First Post:
2015-11-23
Brief Title:
A Trial to Evaluate Safety Tolerability PK and Antiviral Activity of MB-110 in Hepatitis C Virus Infected Patients
Sponsor:
Microbio Co Ltd
Organization:
Microbio Co Ltd
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 volunteersPart A will recruit 2 groups Groups 1 and 2 of 8 healthy volunteers in each group Within each group 8 subjects will be randomized 62 to receive MB-110 versus placeboSubjects 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 62 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 3aPart 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 552 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 51 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 51 to receive MB-110 or placebo once daily for 3 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 3aPart 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 552 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 51 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 51 to receive MB-110 or placebo once daily for 3 consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None