Evaluating HS-10501 Tablets in Healthy Individuals

A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10501 Tablets After Single and Multiple Oral Doses in Healthy Subjects

This study is testing the safety and effects of HS-10501 tablets in healthy people to see how the body handles the drug after one dose and multiple doses over a month.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06359600 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HS-10501 tablets in healthy subjects. It consists of two parts: Part A involves a single dose administration of HS-10501 or a placebo over 8 days, including an exploration of food effects. Part B involves multiple doses of HS-10501 or placebo over a duration of 4 weeks. The study is designed to gather essential data on the drug's effects in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 55 who meet specific weight and BMI criteria.

Not a fit: Patients who are pregnant, lactating, or have significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of HS-10501, potentially leading to new treatment options.

How similar studies have performed: This is the first clinical study of HS-10501, so there are no prior studies to indicate success with similar approaches.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui

• The second hospital of Anhui University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Wei Hu, MD

Conditions Healthy Subjects