A Study of HS-10501 Tablets in Healthy Subjects

Hansoh Pharma

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: HS-10501 tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06359600

HS-10501-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. Must be 18 to 55 years of age (inclusive) healthy male or female;
3. Body weight of at least 50.0 kg for male, and 45.0 kg for female; and Body Mass Index (BMI) within the range of 19.0 to 28.0 kg/m2 (inclusive);
4. Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from the date of signing the informed consent form to 30 days after the last dose;
5. Female subjects must have a negative blood pregnancy test report 3 days before dosing.

Exclusion criteria

1. Pregnant or lactating women;
2. Subjects with a history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities and other diseases, and not suitable for the study as assessed by the investigator;
3. Subjects with clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead ECG during the screening period;
4. Have received major surgery within 3 months before screening or have surgery plan during the study;
5. History of severe infection within 30 days before screening or currently experiencing severe infection;
6. The alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are higher than the upper limit of normal (ULN);
7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);
8. Glycosylated hemoglobin (HbA1c) ≥ 6.0% and fasting blood glucose ≤ 3.9 mmol/L (70 mg/dL) or ≥ 6.1 mmol/L (110 mg/dL) at screening;
9. History of drug abuse and use of hard drugs within 1 year before the study or positive for urine drug screening;
10. Addicted to smoking or smokers who smoke 5 or more cigarettes per day on average within 3 months before screening;
11. History of alcohol abuse, or a single consumption of more than 14 units of alcohol in the past two weeks, or positive for breath alcohol test at screening;
12. Participating in any clinical trial involving drugs or medical devices within 3 months before screening;
13. Blood donation or loss of ≥ 400 mL or blood transfusion within 3 months before screening; blood donation or loss of ≥ 200 mL within 1 month before screening;
14. Subjects with severe allergic disease, or suspected allergy to any ingredient in the study drugs, or allergic constitution;
15. Subjects with concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator;
16. Subjects with a history of pancreatitis, and serum amylase or lipase greater than the ULN;
17. History or family history of medullary thyroid cancer and multiple endocrine neoplasia syndrome type 2;
18. Diet or weight loss treatment within 3 months prior to administration or having weight change of more than 5% or significant change in living habits;
19. Any medication taken within 2 weeks or 5 half-lives (whichever is longer) before screening and any medication expected to be taken throughout the study;
20. Any physiological or psychological diseases or conditions that may increase the risk of the study, affect the subject's compliance with the protocol, or affect the subject's completion of the study, as judged by the investigator;
21. Those who should not be enrolled per the investigator's opinion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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84 participants in 9 patient groups

Cohort 1

Experimental group

Description:

Single dose of HS-10501 administered orally under fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 2

Experimental group

Description:

Single dose of HS-10501 administered orally under fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 3

Experimental group

Description:

Single dose of HS-10501 administered orally under fed and fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 4

Experimental group

Description:

Single dose of HS-10501 administered orally under fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 5

Experimental group

Description:

Single dose of HS-10501 administered orally under fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 6

Experimental group

Description:

Single dose of HS-10501 administered orally under fasted conditions

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 7

Experimental group

Description:

Drugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day.

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 8

Experimental group

Description:

Drugs are given once a day (QD) for 28 days.

Treatment:

Drug: HS-10501 tablet

Drug: Placebo

Cohort 9

Experimental group

Description:

Drugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day.

Treatment:

Drug: HS-10501 tablet

Drug: Placebo