A Study of HS-10501 Tablets in Healthy Subjects

NCT06359600 | Recruiting Phase 1

• 1 other identifier: HS-10501-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment.

  An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.

  Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.

• Number of participants with clinically significant abnormalities in lab tests

  Laboratory tests include blood routine, urine routine, blood biochemistry and coagulation function, etc.

  Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.

• Number of participants with clinically significant change from baseline in vital signs

  Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.

• Change from baseline in Electrocardiogram (ECG)

  ECG parameters including heart rate, PR interval, QRS interval and QTcF, etc.

  Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.

Secondary Outcomes (12)

• Pharmacokinetic (PK) profile of HS-10501 - AUC0-t

  pre-dose to 72 hours post-dose

• Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞

  pre-dose to 72 hours post-dose

• Pharmacokinetic (PK) profile of HS-10501 - Cmax

  pre-dose to 72 hours post-dose

• Pharmacokinetic (PK) profile of HS-10501 - Tmax

  pre-dose to 72 hours post-dose

• Pharmacokinetic (PK) profile of HS-10501 - t1/2

  pre-dose to 72 hours post-dose

Study Arms (9)

Cohort 1

EXPERIMENTAL

Single dose of HS-10501 administered orally under fasted conditions

Drug: HS-10501 tablet; Drug: Placebo

Cohort 2

EXPERIMENTAL

Single dose of HS-10501 administered orally under fasted conditions

Drug: HS-10501 tablet; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: HS-10501 tablet; Drug: Placebo

Cohort 4

EXPERIMENTAL

Single dose of HS-10501 administered orally under fasted conditions

Drug: HS-10501 tablet; Drug: Placebo

Cohort 5

EXPERIMENTAL

Single dose of HS-10501 administered orally under fasted conditions

Drug: HS-10501 tablet; Drug: Placebo

Cohort 6

EXPERIMENTAL

Single dose of HS-10501 administered orally under fasted conditions

Drug: HS-10501 tablet; Drug: Placebo

Cohort 7

EXPERIMENTAL

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

Drug: HS-10501 tablet; Drug: Placebo

Cohort 8

EXPERIMENTAL

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

Drug: HS-10501 tablet; Drug: Placebo

Cohort 9

EXPERIMENTAL

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

Drug: HS-10501 tablet; Drug: Placebo

Interventions

HS-10501 tablet DRUG

Administered orally

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Placebo DRUG

Administered orally

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol;
• Must be 18 to 55 years of age (inclusive) healthy male or female;
• 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);
• 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;
• Female subjects must have a negative blood pregnancy test report 3 days before dosing.

You may not qualify if:

• Pregnant or lactating women;
• 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;
• Subjects with clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead ECG during the screening period;
• Have received major surgery within 3 months before screening or have surgery plan during the study;
• History of severe infection within 30 days before screening or currently experiencing severe infection;
• The alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are higher than the upper limit of normal (ULN);
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);
• 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;
• History of drug abuse and use of hard drugs within 1 year before the study or positive for urine drug screening;
• Addicted to smoking or smokers who smoke 5 or more cigarettes per day on average within 3 months before screening;
• 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;
• Participating in any clinical trial involving drugs or medical devices within 3 months before screening;
• 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;
• Subjects with severe allergic disease, or suspected allergy to any ingredient in the study drugs, or allergic constitution;
• Subjects with concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The second hospital of Anhui University

Hefei, Anhui, 230601, China

RECRUITING

Central Study Contacts

Wei Hu, MD

CONTACT

(+86)13856086475; ayefygcp@163.com

Yijun Du, MD

CONTACT

(+86)13866700016; 2460679232@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 11, 2024
• Study Start: March 14, 2024
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)