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Status unknownNCT02617615Updated Apr 5, 2017

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

A Phase 1 interventional study of MB-110 and Placebo in Chronic Hepatitis C, sponsored by Microbio Co Ltd. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by Microbio Co Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • MB-110
03

In context

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

Microbio Co Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for Part A:

To be eligible to participate in this study, subjects must meet all of the following criteria at screening:

  1. Male or female between 20 to 55 years of age inclusive
  2. 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
  3. 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
  4. Body weight ≥ 50 kg inclusive and body mass index (BMI) in the range of 19.0 to 30.0 kg/m2, extremes included
  5. Good physical and mental health conditions on the basis of medical history and vital signs performed at screening
  6. Healthy on the basis of clinical laboratory tests performed at screening. If the results are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal not to be clinically significant. This determination must be recorded in the subject's source document and initialed by the investigator. This is not applicable to the laboratory abnormalities listed in the exclusion criteria [using the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity criteria-see Section 13.3].
  7. Non-smoking for at least 3 months prior to screening, to be confirmed by a urine cotinine dipstick test

  8. 12-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

10. 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

Exclusion Criteria for Part A:

Subjects must be excluded if they meet any of the following criteria:

  1. Breast-feeding or pregnant female
  2. 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
  3. 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
  4. 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
  5. Clinically relevant, currently active or underlying gastrointestinal, cardiovascular-, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
  6. History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous trials with investigational drugs
  7. Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
  8. Use of concomitant medication, including over-the-counter product, herbal medication and dietary supplement in a period of 14 days before the study
  9. Donation of blood or plasma over 250 mL within 60 days preceding the study

  10. Subjects with one or more of the following laboratory abnormalities at screening as defined by DMID Adult Toxicity Table:

    • Hemoglobin grade 1 or greater (≤ 10.5 gm/dL)
    • Platelet count grade 1 or greater (\< 100,000/mm3)
    • Absolute neutrophil count grade 1 or greater (≤ 1500/mm3)
    • Aspartate transaminase (AST) or alanine aminotransferase (ALT) grade 1 or greater (> 1.1x ULN [upper limit range])
    • Total bilirubin grade 1 or greater (> 1.1x ULN)
    • Lipase grade 1 or greater (> 1.1x ULN)
    • Serum creatinine grade 1 or greater (> 1.1x ULN)
    • Any other laboratory abnormality ≥ grade 1 [Note: Re-testing of abnormal lab values that may lead to exclusion will be allowed once (without prior Sponsor approval). Re-testing will take place during an unscheduled visit in the Screening phase (before admission/baseline)]
  11. Prisoners or subjects compulsorily detained (involuntarily incarcerated) for treatment of a psychiatric illness, or having any history of suicide attempt or depression
  12. Acute illness within 2 weeks prior to dosing, unless approved by the Sponsor's Medical Monitor

Inclusion Criteria for Part B:

To be eligible to participate in this study, subjects must meet all of the following criteria:

  1. Male or female between 20 to 65 years of age inclusive
  2. 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
  3. 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
  4. Body weight ≥ 50 kg inclusive and body mass index (BMI) in the range of 19.0 to 30.0 kg/m2, extremes included
  5. Willing to abstain from caffeine- or xanthine-containing beverages, including coffee and tea, alcohol, grapefruit juice, and bitter oranges during the study period
  6. 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

  7. Presence of chronic hepatitis C (CHC) as documented below:

    • Positive for anti-HCV antibody at least 6 months before screening; or
    • A liver biopsy or Elastoscan/Fibroscan/FibroSURE performed at screening with evidence of CHC, such as the presence of fibrosis and/or inflammation
  8. Positive for anti-HCV antibody at screening
  9. Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver disease
  10. Presence of an HCV RNA level ≥ 1x105 IU/mL at screening
  11. Presence of genotype 1b, 2a, or 3a HCV-infection at screening
  12. Treatment-naïve HCV-infected subjects who are eligible to receive interferon, ribavirin, and HCV protease inhibitors but have a viable HCV treatment plan established with HCV care provider

Exclusion Criteria for Part B:

Subjects must be excluded if they meet any of the following criteria:

  1. Breast-feeding or pregnant female
  2. 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
  3. 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
  4. Hepatitis A or B infection (confirmed by hepatitis A antibody IgM, or hepatitis B surface antigen, respectively) or HIV-1 or HIV-2 infection (confirmed by CLIA test) at study screening
  5. Clinically relevant, currently active or underlying gastrointestinal, cardiovascular-, nervous system, psychiatric, metabolic (e.g., diabetes mellitus), renal, hepatic, respiratory, inflammatory, or infectious disease
  6. History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous trials with investigational drugs
  7. Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
  8. Use of prohibited medications or herbal remedies within 14 days prior to first dose of study drug administration
  9. Donation of blood or plasma over 250 mL within 60 days preceding the study

  10. Subjects with one or more of the following laboratory abnormalities at screening as defined by Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table:

    • Hemoglobin grade 1 or greater (≤ 10.5 gm/dL)
    • Platelet count grade 1 or greater (\< 100,000/mm3)
    • Absolute neutrophil count grade 1 or greater (≤ 1500/mm3)
    • AST or ALT > 5x ULN
    • Total bilirubin > 1.5x ULN
    • Prothrombin time INR >1.5x ULN
    • Lipase grade 1 or greater (> 1.1x ULN)
    • Serum creatinine grade 1 or greater (> 1.1x ULN)
    • Any other laboratory abnormality ≥ grade 2 [Note: Re-testing of abnormal lab values that may lead to exclusion will be allowed once (without prior Sponsor approval). Re-testing will take place during an unscheduled visit in the Screening phase (before admission/baseline)]
  11. Prisoners or subjects compulsorily detained (involuntarily incarcerated) for treatment of a psychiatric illness, or having any history of suicide attempt or depression
  12. Received any other investigational drug within 30 days prior to first dose of study drug administration
  13. Co-infections with HIV-1, HIV-2 or other liver infection
  14. History or evidence of cirrhosis or decompensated liver disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    MB-110

    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 comparator
    Placebo

    in the same #00 hard-gel capsules.

    Drug: Placebo

Interventions

  • DrugMB-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.

    Also known as: DBPR110, NSFA10003S0

  • DrugPlacebo

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

    Also known as: Placebo of MB-110

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events in cohort 1-4

    Time frame: Up to 8 days (plus or minus 1 day)

  2. Incidence of adverse events in cohort 6-8

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

  3. Changes in vital signs from baseline in cohort 1-4

    Time frame: 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)

  4. Changes in vital signs from baseline in cohort 5

    vital signs will be performed

    Time frame: 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)

  5. Changes in vital signs from baseline in cohort 6-8

    Time frame: 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)

  6. Changes in physical examination from baseline in cohort 1-4

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

  7. Changes in physical examination from baseline in cohort 5

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  13. Changes in 12-lead ECG from baseline in cohort 5

    Time frame: 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)

  14. Changes in 12-lead ECG from baseline in cohort 6-8

    Time frame: 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)

  15. 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

    Time frame: Up to 17 days

  16. Incidence of adverse events in cohort 5

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

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

    Time frame: 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)

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

    Time frame: 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)

  19. Maximum plasma concentration (Cmax) in cohort 1-4

    Time frame: 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)

  20. Trough plasma concentration (Cmin) in cohort 1-4

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: -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

  25. 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)

    Time frame: Up to 8 days

  26. 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)

    Time frame: Up to 8 days

  27. 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)

    Time frame: Up to 8 days

  28. 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)

    Time frame: Up to 8 days

  29. 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)

    Time frame: Up to 8 days

  30. 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)

    Time frame: Up to 8 days

  31. 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)

    Time frame: Up to 8 days

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

    Time frame: 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)

  33. 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)

    Time frame: Up to 6 days

  34. 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)

    Time frame: Up to 6 days

  35. 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)

    Time frame: Up to 6 days

  36. 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)

    Time frame: Up to 6 days

  37. 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)

    Time frame: Up to 6 days

  38. 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)

    Time frame: Up to 6 days

  39. 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)

    Time frame: Up to 6 days

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  6. Difference on terminal elimination half-life (t1/2) between cohort 1 and 3

    Time frame: 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)

  7. Difference on terminal elimination rate constant (λz) in cohort 6-8

    Time frame: 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)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2017; primary completion for Jun 2018, 6 months later.

Of 22 phase 1 interventional studies under Hepatitis C, Chronic, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's planned 6 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2015
First posted
Dec 1, 2015
StartEst.
Dec 1, 2017
Primary completionEst.
Jun 2018
CompletionEst.
Dec 2018
Last update
Apr 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02617615
Lead sponsor
Microbio Co Ltd
Responsible party
Sponsor
First posted
Dec 1, 2015
Start date
Dec 1, 2017 (estimated)
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Apr 5, 2017

Study contacts

Ashley Hung
Contact
ashley.hung@microbio.com.tw
+886-2-2570-2088 ext. 390
Karen Wang
Contact
karen.wang@onenessbio.com.tw
+886-2-2570-2088 ext. 316
Kai-Min Chu
principal investigator · Tri-Service General Hospital (TSGH)

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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