AzTrials
AzTrials

Hepatitis B, ChronicPhase 1NCT04248426

A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection

A Phase 1 study testing ATI-2173 in people with Hepatitis B, Chronic, run by Antios Therapeutics, Inc at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a double-blinded, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and antiviral activity in both healthy volunteers and volunteers with chronic hepatitis B virus infection. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
ATI-2173
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
3 sitesin 3 countries
Study dates
5 Feb 2020to 18 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects:
  • Provision of signed and dated informed consent form (ICF)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • If female, meets 1 of the following criteria:
  • Is of childbearing potential and agrees to use an accepted contraceptive method. Acceptable method of contraception include:
  • Abstinence from heterosexual intercourse from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer
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  • Male partner vasectomized at least 6 months prior to the first study drug administration
  • Use a systemic contraceptive or an intrauterine device (with or without hormones), from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer, with a male condom or a diaphragm/cervical cap plus spermicide, from the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer Or
  • Male partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable contraceptive method from the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer Or
  • Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration and follicle-stimulating hormone levels ≥ 40 mIU/mL at screening)
  • If male, meets 1 of the following criteria:
  • Is able to procreate and agrees to use 1 of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes 1 of the following:
  • Abstinence from heterosexual intercourse
  • Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) or
  • Is unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to the first study drug administration)
  • Light-, non- or ex-smoker (A light-smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration. An ex smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
  • Healthy subjects (Phase 1a):
  • Male or female, aged at least 18 years but not older than 55 years
  • Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive
  • HBV-infected subjects (Phase 1b):
  • Male or female, aged at least 18 years but not older than 65 years
  • BMI within 18.0 kg/m2 to 35.0 kg/m2, inclusive
  • Serum HBsAg positive at screening and at least 6 months prior to screening
  • Serum HBeAg positive and HBV DNA ≥ 20,000 IU/mL, or serum HBeAg negative and HBV DNA ≥ 2,000 IU /mL at screening
  • ALT and AST <5 times the upper limit of normal (ULN) at screening and prior to the first study drug administration

Who cannot join

  • All subjects:
  • Female who is lactating at screening
  • Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
  • History of significant hypersensitivity to clevudine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of clinically significant muscle disorders, myopathies or other forms of liver disease
Show all 33Show fewer
  • Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
  • Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
  • Any history of tuberculosis
  • Inclusion in a previous cohort for this clinical study
  • Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
  • Active illicit drug use including, but not limited to, cocaine, heroin and methamphetamine (the use of cannabinoid is acceptable)
  • Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
  • Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration
  • Healthy subjects (Phase 1a):
  • Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the 28 days prior to the first study drug administration
  • Presence or history of clinically significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
  • Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
  • Use of any prescription drugs including amiodarone (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
  • HBV-infected subjects (Phase 1b):
  • Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Use of amiodarone in the 28 days prior to the first study drug administration
  • Presence or history of clinically significant gastrointestinal or kidney disease, or surgery that may affect drug bioavailability
  • Cirrhosis of the liver as determined by one of the following:
  • A score greater than F2 for liver fibrosis by FibroScan or FibroSure test within 6 months prior to screening or at the time of screening OR
  • A score greater than F2 on liver biopsy within 12 months prior to screening or at the time of screening
  • Medical history or known presence of hepatocellular carcinoma
  • Previous treatment for hepatitis B virus, including nucleoside therapy
  • Acute infection or any other clinically significant illness within 14 days of randomization
  • History of organ transplantation
  • Uncontrolled hypertension
  • Positive screening results to HIV Ag/Ab combo, hepatitis C virus or hepatitis D virus tests

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Canada1 site

  • Altasciences

    Montreal, Quebec, H3P 3P1

Other trials in Canada

Moldova1 site

  • Republican Clinical Hospital "Timofei Mosneaga" Arensia EM Unit

    Chisinau, Republic of Moldova

Other trials in Moldova

Ukraine1 site

  • Medical Center of Limited Liability Company "Harmoniya krasy" Department of Clinical Trials

    Kyiv

Other trials in Ukraine

About this study

This is a double-blinded, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and antiviral activity in both healthy volunteers and volunteers with chronic hepatitis B virus infection. Healthy volunteers will be administered either a single oral dose or multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug. Volunteers with a diagnosis of chronic hepatitis B virus infection will be administered multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

Being tested
ATI-2173, ATI-2173 Placebo
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI-2173Drug

    ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth.

  • ATI-2173 PlaceboDrug

    ATI-2173 Placebo is used as an inactive comparator to ATI-2173. It will be dosed as a capsule by mouth.

Study groups in NCT04248426
Study groupRoleWhat they receive
ATI-2173ExperimentalNot described
Receives: Drug: ATI-2173
ATI-2173 PlaceboPlacebo comparatorNot described
Receives: Drug: ATI-2173 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE)

    Measured: Through study completion, an average of 1 year

  2. The percentage of subjects who experienced at least one treatment emergent serious AE (SAE).

    Measured: Through study completion, an average of 1 year

  3. Percentage of subjects who experienced a treatment-emergent dose limiting toxicity (DLT)

    Measured: Through study completion, an average of 1 year

  4. Percentage of subjects who experienced at least one treatment emergent Grade 1, 2, 3, 4 or 5 laboratory abnormality

    Measured: Through study completion, an average of 1 year

  5. Percentage of subjects who discontinued study drug due to a TEAE

    Measured: Through study completion, an average of 1 year

Secondary outcomes (42)

  1. Peak plasma concentration (Cmax) of ATI-2173 and clevudine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  2. Food effect on Peak plasma concentration (Cmax) of ATI-2173 and clevudine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  3. Peak plasma concentration (Cmax) of ATI-2173 and clevudine in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  4. Peak plasma concentration (Cmax) of ATI-2173 and clevudine in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  5. Time of maximum observed plasma concentration (Tmax) of ATI-2173 and clevudine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  6. Food Effect on Time of maximum observed plasma concentration (Tmax) of ATI-2173 and clevudine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  7. Time of maximum observed plasma concentration (Tmax) of ATI-2173 and clevudine in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  8. Time of maximum observed plasma concentration (Tmax) of ATI-2173 and clevudine in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  9. Area under plasma concentration time curve (AUC) of ATI-2173 and clevudine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  10. Food Effect on Area under the concentration time curve (AUC0-t) from time 0 (dose administration) to the time of last quantifiable concentration (TLQC) of ATI-2173 and clevudine

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  11. Food Effect on Area under the concentration time curve (AUC0-inf) extrapolated to infinity, calculated as AUC0-t + CLQC/λZ, where CLQC is the measured concentration at time TLQC in ATI-2173 and clevudine

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  12. Area under the concentration time curve from time 0 (dose administration) to 24 hours (AUC0-24) in ATI-2173 and clevudine in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  13. Area under the concentration time curve from time 0 (dose administration) to 24 hours (AUC0-24) in ATI-2173 and clevudine in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  14. Terminal elimination half-life (t1/2) of ATI-2173 in plasma in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours

  15. Terminal elimination half-life (t1/2) of ATI-2173 in plasma in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  16. Terminal elimination half-life (t1/2) of ATI-2173 in plasma in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  17. Trough Peak plasma concentration (Ctrough) of ATI-2173 and clevudine in Multiple Dose Healthy Volunteers

    Measured: Pre-dose on days 3, 5, 7, 10, and 13.

  18. Trough Peak plasma concentration (Ctrough) of ATI-2173 and clevudine in Multiple Dose HBV Infected Patients

    Measured: Pre-dose on days 3, 5, 7, 10, 14 and 21

  19. Minimum observed plasma concentration (Cmin) of ATI-2173 and clevudine in a dosing interval in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  20. Minimum observed plasma concentration (Cmin) of ATI-2173 and clevudine in a dosing interval in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  21. Cumulative amount of drug excreted in urine over all time intervals (Ae) in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, and 96-120 hours

  22. Cumulative amount of drug excreted in urine over all time intervals (Ae) in Multiple Dose Healthy Volunteers

    Measured: Pre-dose on Day 1, post-dose on Days 1 & 14 at 0-4, 4-8, 8-12, 12-24 hours

  23. Cumulative amount of drug excreted in urine over all time intervals (Ae) in Multiple Dose HBV Infected Patients

    Measured: Pre-dose on Day 1, post-dose on Days 1 & 28 at 0-4, 4-8 and 8-24 hours

  24. Apparent metabolic clearance (mCLr) of clevudine in urine in Single Dose Healthy Volunteers

    Measured: Pre-dose, post-dose at 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, and 96-120 hours

  25. Apparent metabolic clearance (mCLr) of clevudine in urine in Multiple Dose Healthy Volunteers

    Measured: Pre-dose on Day 1, post-dose on Days 1 & 14 at 0-4, 4-8, 8-12, 12-24 hours

  26. Apparent metabolic clearance (mCLr) of clevudine in urine in Multiple Dose HBV Infected Patients

    Measured: Pre-dose on Day 1, post-dose on Days 1 & 28 at 0-4, 4-8 and 8-24 hours

  27. Accumulation ratio of ATI-2173 and clevudine in plasma (RAC) evaluated by comparing Day 14 (Ph1a) Cmax to Day 1 Cmax in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  28. Accumulation ratio of ATI-2173 and clevudine in plasma (RAC) evaluated by comparing Day 28 (Ph1b) Cmax to Day 1 Cmax in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  29. Accumulation ratio of ATI-2173 and clevudine in plasma (RAC) evaluated by comparing Day 14 (Ph1a) AUCtau to Day 1 AUC0-24 in Multiple Dose Healthy Volunteers

    Measured: Day 1 & Day 14: Pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Day 14 only: post-dose at 48, 72, 144, 216, and 312 hours

  30. Accumulation ratio of ATI-2173 and clevudine in plasma (RAC) evaluated by comparing Day 28 (Ph1b) AUCtau to Day 1 AUC0-24 in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  31. Resistance Mutations in Multiple Dose HBV Infected Patients

    To assess the emergence of resistance mutations in HBV-infected subjects. The frequency of targeted mutations may be calculated in each subject.

    Measured: Day -1, Day 1, Day 7, Day 14, Day 21, Day 28, Day 31, Day 37, Day 55, Day 111, Day 195

  32. Maximum observed HBV DNA change (reduction) from baseline through Day 28 (Emax) in Multiple Dose HBV Infected Patients

    Measured: Screening, Day -1, 7, 14, 21, 28

  33. Maximum observed HBV DNA change (reduction) from baseline through end of study (Emax) in Multiple Dose HBV Infected Patients

    Measured: Screening, Day -1, 7, 14, 21, 28, 31, 37, 55, 111, and 195

  34. Time (day) of maximum observed effect through Day 28 (TEmax) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours

  35. Time (day) of maximum observed effect through end of study (TEmax) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours

  36. Area under the effect concentration time curve from time 0 (first dose administration) to Day 28 that is above baseline (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours

  37. Area under the effect concentration time curve from time 0 (first dose administration) to end of study (24 weeks post last dose) that is above baseline (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  38. Area under the effect concentration time curve from time 0 (first dose administration) to Day 28 that is below baseline (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours

  39. Area under the effect concentration time curve from time 0 (first dose administration) to end of study (24 weeks post last dose) that is below baseline (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  40. Area under the effect concentration time curve from time 0 (first dose administration) to Day 28 (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours

  41. Area under the effect concentration time curve from time 0 (first dose administration) to end of study (24 weeks post last dose) (AUEC) in Multiple Dose HBV Infected Patients

    Measured: Day 1: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours; Day 28: pre-dose, post-dose at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 144, 216 and 312 hours

  42. ALT/AST Concentration versus Time in Multiple Dose HBV Infected Patients

    Measured: Screening, Day -1, 1, 3, 7, 10, 14, 21, 28, 34, 37, 41, and 55

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start5 Feb 2020
  3. Primary completion18 May 2021
  4. Study completion18 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248426
Sponsor's protocol ID
ANTT101
Status last verified
Aug 2021
First submitted
22 Jan 2020
Last updated
19 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peek SF, Cote PJ, Jacob JR, Toshkov IA, Hornbuckle WE, Baldwin BH, Wells FV, Chu CK, Gerin JL, Tennant BC, Korba BE. Antiviral activity of clevudine [L-FMAU, (1-(2-fluoro-5-methyl-beta, L-arabinofuranosyl) uracil)] against woodchuck hepatitis virus replication and gene expression in chronically infected woodchucks (Marmota monax). Hepatology. 2001 Jan;33(1):254-66. doi: 10.1053/jhep.2001.20899.

    PubMed 11124844

  • Marcellin P, Mommeja-Marin H, Sacks SL, Lau GK, Sereni D, Bronowicki JP, Conway B, Trepo C, Blum MR, Yoo BC, Mondou E, Sorbel J, Snow A, Rousseau F, Lee HS. A phase II dose-escalating trial of clevudine in patients with chronic hepatitis B. Hepatology. 2004 Jul;40(1):140-8. doi: 10.1002/hep.20257.

    PubMed 15239097

  • Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH, Yoo BC. A 12-week clevudine therapy showed potent and durable antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology. 2006 May;43(5):982-8. doi: 10.1002/hep.21166.

    PubMed 16628625

  • Lim SG, Leung N, Hann HW, Lau GK, Trepo C, Mommeja-Marin H, Moxham C, Sorbel J, Snow A, Blum MR, Rousseau F, Marcellin P. Clinical trial: a phase II, randomized study evaluating the safety, pharmacokinetics and anti-viral activity of clevudine for 12 weeks in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2008 Jun;27(12):1282-92. doi: 10.1111/j.1365-2036.2008.03686.x. Epub 2008 Mar 22.

    PubMed 18363895

  • Yoo BC, Kim JH, Chung YH, Lee KS, Paik SW, Ryu SH, Han BH, Han JY, Byun KS, Cho M, Lee HJ, Kim TH, Cho SH, Park JW, Um SH, Hwang SG, Kim YS, Lee YJ, Chon CY, Kim BI, Lee YS, Yang JM, Kim HC, Hwang JS, Choi SK, Kweon YO, Jeong SH, Lee MS, Choi JY, Kim DG, Kim YS, Lee HY, Yoo K, Yoo HW, Lee HS. Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology. 2007 May;45(5):1172-8. doi: 10.1002/hep.21629.

    PubMed 17464992

  • Yoo BC, Kim JH, Kim TH, Koh KC, Um SH, Kim YS, Lee KS, Han BH, Chon CY, Han JY, Ryu SH, Kim HC, Byun KS, Hwang SG, Kim BI, Cho M, Yoo K, Lee HJ, Hwang JS, Kim YS, Lee YS, Choi SK, Lee YJ, Yang JM, Park JW, Lee MS, Kim DG, Chung YH, Cho SH, Choi JY, Kweon YO, Lee HY, Jeong SH, Yoo HW, Lee HS. Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology. 2007 Oct;46(4):1041-8. doi: 10.1002/hep.21800.

    PubMed 17647293

  • Fleischer RD, Lok AS. Myopathy and neuropathy associated with nucleos(t)ide analog therapy for hepatitis B. J Hepatol. 2009 Oct;51(4):787-91. doi: 10.1016/j.jhep.2009.06.011. Epub 2009 Jul 1.

    PubMed 19665816

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Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATI-2173 in people with Hepatitis B, Chronic, run by Antios Therapeutics, Inc at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, Moldova, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE) (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248426, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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