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Chronic Hepatitis bPhase 1NCT05298332

Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects

A Phase 1 study testing ATI-2173 50 mg in people with Chronic Hepatitis b, run by Antios Therapeutics, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a food effect analysis in Non-Asian healthy subjects. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis b
What is being tested?
ATI-2173 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
29 Mar 2022to 22 Aug 2022
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 59 years
  • All sexes
  • Healthy volunteers accepted
  • 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 (including ability and willingness to abstain from alcohol from 48 hours prior to the first study drug administration until discharge) and availability for the duration of the study
  • Healthy adult male or female
  • Aged between 18 and 59 years, inclusive
  • Weight ≥ 50.0 kg and ≤ 100 kg
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  • Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
  • Non- or ex-smoker (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)
  • Suitable veins for cannulation or repeated venipuncture as assessed by an Investigator at Screening
  • 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
  • Agrees to abstain from blood or plasma donation from the Screening visit until 3 months after the last study drug administration
  • If female, must meet one of the following criteria:
  • Is of childbearing potential and agrees to use an acceptable contraceptive method.
  • Acceptable contraceptive methods include:
  • Abstinence from heterosexual intercourse from Screening through to at least 60 days after the last study drug administration
  • Male partner vasectomized at least 180 days prior to Screening
  • Double-barrier method (eg, male condom, spermicide and diaphragm or male condom, spermicide and cervical cap used simultaneously) from Screening through to at least 30 days after the last study drug administration
  • One of the following contraceptive methods with a barrier method (eg, male condom) from at least 28 days prior to the first study drug administration through to at least 60 days after the last study drug administration:
  • Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
  • Intrauterine device (with or without hormones) OR
  • Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation/occlusion) or in a postmenopausal state (at least 1 year without menses without an alternative medical condition prior to Screening), as confirmed by follicle-stimulating hormone levels (≥ 40 mIU/mL).
  • A male study subject that engages in sexual activity that has the risk of pregnancy must:
  • Agree to use a double-barrier method (eg, male condom, spermicide, and diaphragm or male condom, spermicide, and cervical cap used simultaneously) if female partner is of child-bearing potential or be abstinent from heterosexual intercourse from Screening to at least 90 days after the last study drug administration or be unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to Screening AND
  • Agree to not donate sperm during the study and for at least 90 days after the last study drug administration.
  • For Cohort 1 only:
  • The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent.
  • The subject must have lived outside of Japan for no more than 10 years.
  • The subject must have not significantly changed their diet and lifestyle since leaving Japan.
  • For Cohort 2 only:
  • The subject must have been born in China or Chinese subjects who were born in Taiwan, Hong Kong, Macau, Mongolia, or Singapore and have both parents and 4 grandparents of Chinese descent.
  • The subject must have lived outside of Chinese for no more than 10 years.
  • The subject must have not significantly changed their diet and lifestyle since leaving China.
  • For Cohort 3 only:
  • The subjects must be of Non-Asian descent, as evidenced by verbal confirmation that both parents and all 4 grandparents are Non-Asian.

Who cannot join

  • Female who is lactating
  • Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
  • Blood pressure and pulse rate outside normal range and clinically significant at Screening or prior to the first study drug administration, in the opinion of an Investigator
  • History of hypersensitivity to ATI-2173 or clevudine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability including but not limited to cholecystectomy (excluding appendectomy)
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease, in the opinion of an Investigator
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  • Presence of clinically significant ECG abnormalities at Screening or prior to the first study drug administration, in the opinion of an Investigator
  • Presence of clinically significant muscle disorders, myopathies or other forms of liver disease, in the opinion of an Investigator
  • Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) equation at Screening or prior to the first study drug administration
  • Unexplained persistent elevations of serum transaminases or creatine kinase (CK) levels that are clinically significant per Investigator discretion, at Screening or prior to the first study drug administration
  • Immunization with a Coronavirus Disease 2019 (COVID-19) vaccine in the 14 days prior to the first study drug administration
  • Scheduled immunization with a COVID-19 vaccine (first, second or booster dose) during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason
  • 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
  • Use of any prescription drugs (except systemic contraception and intrauterine devices), including but not limited to inducers, inhibitors, or substrates of P-glycoprotein and CYP3A4, 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 or that could potentially interact with the study drug
  • Use of St. John's wort in the 28 days prior to the first study drug administration
  • Any history of tuberculosis
  • Use of quinine-containing products (eg, tonic water), grapefruit products, pomelo products, Seville orange products, including supplements containing Citrus aurantium or "bitter orange", in the 14 days prior to the first study drug administration
  • Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first study drug administration
  • Positive test results for HIV-1/HIV-2 antibodies, hepatitis B surface antigen or hepatitis C antibody at Screening
  • Any other clinically significant abnormalities in laboratory test results at Screening or prior to the first study drug administration that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
  • Inclusion in a previous group for this clinical study
  • Participation in another clinical study with a non-biologic Investigational Product (IP) or new formulation of a marketed non-biologic drug in the 30 days prior to dosing
  • Participation in another clinical study with a biologic (marketed or investigational) in the 90 days or 5 half-lives (whichever is longer) prior to dosing
  • Donation of plasma in the 7 days prior to Screening
  • Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior Screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, 3-Cohort, Parallel, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose ATI-2173 50 mg in Healthy Japanese, Chinese, and Non-Asian Subjects

This is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a food effect analysis in Non-Asian healthy subjects.

Being tested
ATI-2173 50 mg
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-2173 50 mgDrug

    ATI-2173 is a phosphoramidate prodrug of the oral, non-chain terminating nucleoside analog clevudine being developed by Antios Therapeutics, Inc. for treatment of men and women with chronic hepatitis B (CHB)

Study groups in NCT05298332
Study groupRoleWhat they receive
ATI-2173 50 mg JapaneseExperimentalHealthy adult Japanese subjects will receive 50 mg of ATI-2173
Receives: Drug: ATI-2173 50 mg
ATI-2173 50 mg ChineseExperimentalHealthy adult Chinese subjects will receive 50 mg of ATI-2173
Receives: Drug: ATI-2173 50 mg
ATI-2173 50 mg Non-AsianExperimentalHealthy adult non-Asian subjects will receive 50 mg of ATI-2173
Receives: Drug: ATI-2173 50 mg

What is being measured

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

  1. Cmax of ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  2. Tmax ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  3. AUC0-t ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  4. AUC0-inf ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  5. T1/2 ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  6. CL/F of ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  7. Vz/F of ATI-2173, clevudine, and M1 in plasma

    Measured: Through the end of study, average of 3 months

  8. Ae of ATI-2173, clevudine, and M1 in urine

    Measured: Through the end of study, average of 3 months

  9. CLR of ATI-2173 in urine

    Measured: Through the end of study, average of 3 months

  10. mCLR of clevudine, and M1 in urine

    Measured: Through the end of study, average of 3 months

Secondary outcomes (4)

  1. Number of adverse events

    Measured: Through the end of study, average of 3 months

  2. Cmax of ATI-2173, clevudine, and M1 in plasma for food effect

    Measured: Through the end of study, average of 3 months

  3. AUC0-72 of ATI-2173, clevudine, and M1 in plasma for food effect

    Measured: Through the end of study, average of 3 months

  4. AUC0-inf of ATI-2173, clevudine, and M1 in plasma for food effect

    Measured: Through the end of study, average of 3 months

Timeline

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

  1. First posted28 Mar 2022
  2. Study start29 Mar 2022
  3. Primary completion22 Aug 2022
  4. Study completion22 Aug 2022

Why it stopped: Terminated by the Sponsor

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298332
Sponsor's protocol ID
ANTT104
Status last verified
Nov 2022
First submitted
24 Feb 2022
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATI-2173 50 mg in people with Chronic Hepatitis b, run by Antios Therapeutics, Inc at 1 site in United States.

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 34 inclusion and 26 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: stopped early, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 was stopped early (reason given: Terminated by the Sponsor). Results are not available in the source record.

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?

Cmax of ATI-2173, clevudine, and M1 in plasma (time frame: Through the end of study, average of 3 months). The study lists 10 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 NCT05298332.

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 18 Nov 2022.

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