Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects

NCT05298332 | Terminated Phase 1 FDA Drug

• 1 other identifier: ANTT104
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (10)

• Cmax of ATI-2173, clevudine, and M1 in plasma

  Through the end of study, average of 3 months

• Tmax ATI-2173, clevudine, and M1 in plasma

  Through the end of study, average of 3 months

• AUC0-t ATI-2173, clevudine, and M1 in plasma

  Through the end of study, average of 3 months

• AUC0-inf ATI-2173, clevudine, and M1 in plasma

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

• Ae of ATI-2173, clevudine, and M1 in urine

  Through the end of study, average of 3 months

• CLR of ATI-2173 in urine

  Through the end of study, average of 3 months

• mCLR of clevudine, and M1 in urine

  Through the end of study, average of 3 months

Secondary Outcomes (4)

• Number of adverse events

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

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

  Through the end of study, average of 3 months

Study Arms (3)

ATI-2173 50 mg Japanese

EXPERIMENTAL

Healthy adult Japanese subjects will receive 50 mg of ATI-2173

Drug: ATI-2173 50 mg

ATI-2173 50 mg Chinese

EXPERIMENTAL

Healthy adult Chinese subjects will receive 50 mg of ATI-2173

Drug: ATI-2173 50 mg

ATI-2173 50 mg Non-Asian

EXPERIMENTAL

Healthy adult non-Asian subjects will receive 50 mg of ATI-2173

Drug: ATI-2173 50 mg

Interventions

ATI-2173 50 mg DRUG

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)

ATI-2173 50 mg Chinese; ATI-2173 50 mg Japanese; ATI-2173 50 mg Non-Asian

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Antios Therapeutics, Inc: lead

Study Sites (1)

Altasciences

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 28, 2022
• Study Start: March 29, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

US (1)