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

NCT02617615 | Unknown Phase 1 FDA Drug

• 1 other identifier: MB110CLCT01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis C

Keywords

MB-110

Outcome Measures

Primary Outcomes (40)

• Incidence of adverse events in cohort 1-4

  Up to 8 days (plus or minus 1 day)

• Incidence of adverse events in cohort 6-8

  Up to 17 days (14 days plus or minus 1 day after dosing for 3 consecutive days)

• Changes in vital signs from baseline in cohort 1-4

  at screening visit, day-1, pre-dose (-2 to 0 hr), and post-dose (2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr, 48 hr, 72 hr, and 96 hr) and Day 8 (plus or minus 1 day)

• Changes in vital signs from baseline in cohort 5

  vital signs will be performed

  at screening visit, day-1, post-1st, -2nd, -3rd, -4th, -5th dose (4 hr±15 min and 6 hr±15 min), discharge day (Day 9), Day 12, and Day 19 (14 days plus or minus 1 day after dosing for 5 consecutive days)

• Changes in vital signs from baseline in cohort 6-8

  at screening visit, day-1, post-1st, -2nd, -3rd dose (4 hr±15 min and 6 hr±15 min), discharge day (Day 7), Day 13, and Day 17 (14 days plus or minus 1 day after dosing for 3 consecutive days)

• Changes in physical examination from baseline in cohort 1-4

  at screening visit, day-1, discharge day (Day 5), and Day 8 (plus or minus 1 day)

• Changes in physical examination from baseline in cohort 5

  at screening visit, day-1, discharge day (Day 9), Day 12, and Day 19 (14 days plus or minus 1 day after dosing for 5 consecutive days)

• Changes in physical examination from baseline in cohort 6-8

  at screening visit, day-1, discharge day (Day 7), Day 13, and Day 17 (14 days plus or minus 1 day after dosing for 3 consecutive days)

• Changes in safety laboratory values (biochemistry, hematology, coagulation, and urinalysis) from baseline in cohort 1-4

  at screening visit, day-1, and post-dose (12 hr±30 min, 48 hr±30 min, and 96 hr±30 min), and Day 8 (plus or minus 1 day)

• Changes in safety laboratory values (biochemistry, hematology, coagulation, and urinalysis) from baseline in cohort 5

  at screening visit, day-1, post-1st, -3rd, and -5th dose (12 hr±30 min), Day 7, discharge day (Day 9), and Day 12 (7 days plus or minus 1 day after dosing for 5 consecutive days)

• Changes in safety laboratory values (biochemistry, hematology, coagulation, and urinalysis) from baseline in cohort 6-8

  at screening visit, day-1, 12 hr±30 min post-1st, 12 hr±30 min post-3rd, Day 5, discharge day (Day 7), and Day 13 (10 days plus or minus 1 day after dosing for 3 consecutive days)

• Changes in 12-lead ECG from baseline in cohort 1-4

  at screening visit, day-1, pre-dose (-2 to 0 hr), and post-dose (2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr, 48 hr, 72 hr, and 96 hr), and Day 8 (plus or minus 1 day)

• Changes in 12-lead ECG from baseline in cohort 5

  at screening visit, day-1, post-1st, -2nd, -3rd, -4th, -5th dose (4 hr±15 min and 6 hr±15 min), discharge day (Day 9), and Day 12 (7 days plus or minus 1 day after dosing for 5 consecutive days)

• Changes in 12-lead ECG from baseline in cohort 6-8

  at screening visit, day-1, post-1st, -2nd, -3rd dose (4 hr±15 min and 6 hr±15 min), discharge day (Day 7), and Day 13 (10 days plus or minus 1 day after dosing for 3 consecutive days)

• Change in plasma viral RNA from baseline in cohort 6-8

  Blood for HCV RNA level determination will be collected at screening visit, day-1, Day 1 ( pre-1st dose (-2 to 0 hr), post-1st dose (8 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose)), Day 2 (post-2nd dose (12 hr±15 min and 24 hr±15 min)), Day 3 (post-3rd dose (12 hr±15 min, 24 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)), Day 13, and Day 17

  Up to 17 days

• Incidence of adverse events in cohort 5

  Up to 19 days (14 days plus or minus 1 day after dosing for 5 consecutive days)

• Area under the plasma concentration time curve from 0 to the last measurable concentration (AUC0-t) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Area under the plasma concentration time curve from 0 to infinity (AUC0-inf) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Maximum plasma concentration (Cmax) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Trough plasma concentration (Cmin) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Time at which maximum plasma concentration (Tmax) is observed in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Terminal elimination half-life (t1/2) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Terminal elimination rate constant (λz) in cohort 1-4

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Urine PK parameters: the amount of study drug excreted into urine and urine recovery rate (Ae%) in cohort 1-4

  -2-0 hr, 0-6 hr, 6-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr post-dose

• Area under the plasma concentration time curve from 0 to the last measurable concentration (AUC0-t) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Area under the plasma concentration time curve from 0 to infinity (AUC0-inf) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Maximum plasma concentration (Cmax) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Trough plasma concentration (Cmin) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Time at which maximum plasma concentration (Tmax) is observed in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Terminal elimination half-life (t1/2) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Terminal elimination rate constant (λz) in cohort 5

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3 and Day 4: pre-3rd, -4th dose (-2 to 0 hr) Day 5: pre-5th dose (-2 to 0 hr), post-5th dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 8 days

• Urine PK parameters: the amount of study drug excreted into urine and urine recovery rate (Ae%) in cohort 5

  Day 1: pre-1st dose (-2-0 hr), post-1st dose (0-6 hr, 6-12 hr, 12-24 hr) Day 5: post-5th dose (0-6 hr, 6-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, and 72-96 hr)

• Area under the plasma concentration time curve from 0 to the last measurable concentration (AUC0-t) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Area under the plasma concentration time curve from 0 to infinity (AUC0-inf) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Maximum plasma concentration (Cmax) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Trough plasma concentration (Cmin) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Time at which maximum plasma concentration (Tmax) is observed in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Terminal elimination half-life (t1/2) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Terminal elimination rate constant (λz) in cohort 6-8

  Day 1: pre-1st dose (-2 to 0 hr), post-1st dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min before the 2nd dose) Day 3: pre-3rd dose (-2 to 0 hr), post-3rd dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

  Up to 6 days

• Urine PK parameters: the amount of study drug excreted into urine and urine recovery rate (Ae%) in cohort 6-8

  Day 1: pre-1st dose (-2-0 hr), post-1st dose (0-4 hr, 4-8 hr, 8-12 hr, 12-16 hr, and 16-24 hr) Day 3: post-3rd dose (0-4 hr, 4-8 hr, 8-12 hr, 12-16 hr, 16-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, and 72-96 hr)

Secondary Outcomes (7)

• Difference on area under the plasma concentration time curve from 0 to the last measurable concentration (AUC0-t) between cohort 1 and 3

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Difference on area under the plasma concentration time curve from 0 to infinity (AUC0-inf) between cohort 1 and 3

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Difference on maximum plasma concentration (Cmax) between cohort 1 and 3

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Difference on trough plasma concentration (Cmin) between cohort 1 and 3

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

• Difference on time at which maximum plasma concentration (Tmax) is observed between cohort 1 and 3

  pre-dose (-2 to 0 hr) and post-dose (1 hr±3 min, 2 hr±5 min, 3 hr±10 min, 4 hr±10 min, 6 hr±15 min, 8 hr±15 min, 12 hr±15 min, 16 hr±15 min, 24 hr±15 min, 36 hr±15 min, 48 hr±15 min, 72 hr±15 min, 96 hr±15 min)

Study Arms (2)

MB-110

EXPERIMENTAL

oral hard-gel capsule formulation. One dose strength, 25 mg of MB-110, will be filled into the #00 hard-gel capsule.

Drug: MB-110

Placebo

PLACEBO COMPARATOR

in the same #00 hard-gel capsules.

Drug: Placebo

Interventions

MB-110 DRUG

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.

Also known as: DBPR110, NSFA10003S0

MB-110

Placebo DRUG

It will be identical in appearance and similar in weight to the MB-110 hard-gel capsule.

Also known as: Placebo of MB-110

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, subjects must meet all of the following criteria at screening:
• Male or female between 20 to 55 years of age inclusive
• For females, not breast-feeding, not pregnant, post-menopausal for at least 2 years, surgically sterile, or willing to use a double barrier method \[intrauterine device (IUD) plus condom, spermicidal gel plus condom\] of contraception, or other effective contraceptive methods from screening until 30 days after the last dose of study drug
• For males, willing to use a reliable form of contraception (use of a male condom with spermicide or a partner fulfilling the above criteria), or abstinence from screening until 30 days after the last dose of study drug
• Body weight ≥ 50 kg inclusive and body mass index (BMI) in the range of 19.0 to 30.0 kg/m2, extremes included
• Good physical and mental health conditions on the basis of medical history and vital signs performed at screening

You may not qualify if:

• Non-smoking for at least 3 months prior to screening, to be confirmed by a urine cotinine dipstick test
• lead electrocardiogram (ECG) consistent with normal cardiac conduction and function:
• Heart rate (HR) between 50 and 100 bpm
• QTcF interval ≤ 430 ms (male) or ≤ 450 ms (female)
• QRS interval lower than 120 ms
• PR interval ≤ 200 ms
• Willing to abstain from caffeine- or xanthine-containing beverages and food, including coffee and tea, alcohol, grapefruit juice, and bitter oranges during the study period
• \. Willing to sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
• Subjects must be excluded if they meet any of the following criteria:
• Breast-feeding or pregnant female
• History of heart arrhythmias (any clinically relevant) or having baseline prolongation of QTcF interval \> 430 ms (male) or \> 450 ms (female), history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT syndrome), or a HR (supine pulse as obtained from vital signs) \< 50 bpm or \> 100 bpm
• History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the study procedures
• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) or HIV-1 or HIV-2 infection (confirmed by CLIA test) at study screening
• Clinically relevant, currently active or underlying gastrointestinal, cardiovascular-, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
• History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous trials with investigational drugs

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (1)

Microbio Co., Ltd.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

DBPR110

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai-Min Chu

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Hung

CONTACT

+886-2-2570-2088; ashley.hung@microbio.com.tw

Karen Wang

CONTACT

+886-2-2570-2088; karen.wang@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

TW (1)