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Nucleoside Analogue
ATI-2173 50 mg Non-Asian for Chronic Hepatitis B
Phase 1
Waitlist Available
Research Sponsored by Antios Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the end of study, average of 3 months
Awards & highlights
Summary
This trial is testing a new drug called ATI-2173 in healthy Japanese, Chinese, and Non-Asian people. The researchers want to see how the drug moves through the body, if it is safe, and if people can take it without significant side effects. They are also checking if food affects how the drug works in Non-Asian participants.
Eligible Conditions
- Chronic Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the end of study, average of 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the end of study, average of 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC0-inf ATI-2173, clevudine, and M1 in plasma
AUC0-t ATI-2173, clevudine, and M1 in plasma
Ae of ATI-2173, clevudine, and M1 in urine
+7 moreSecondary outcome measures
AUC0-72 of ATI-2173, clevudine, and M1 in plasma for food effect
AUC0-inf of ATI-2173, clevudine, and M1 in plasma for food effect
Cmax of ATI-2173, clevudine, and M1 in plasma for food effect
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: ATI-2173 50 mg Non-AsianExperimental Treatment1 Intervention
Healthy adult non-Asian subjects will receive 50 mg of ATI-2173
Group II: ATI-2173 50 mg JapaneseExperimental Treatment1 Intervention
Healthy adult Japanese subjects will receive 50 mg of ATI-2173
Group III: ATI-2173 50 mg ChineseExperimental Treatment1 Intervention
Healthy adult Chinese subjects will receive 50 mg of ATI-2173
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI-2173 50 mg
2021
Completed Phase 1
~40
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Antios Therapeutics, IncLead Sponsor
5 Previous Clinical Trials
198 Total Patients Enrolled
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