Last updated: April 7, 2024
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Healthy Volunteers
Treatment
HS-10501 tablet
Placebo
Clinical Study ID
NCT06359600
HS-10501-101
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Able and willing to provide written informed consent and to comply with the studyprotocol;
- 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 protocolspecified effective methods of contraception from the date of signing the informedconsent form to 30 days after the last dose;
- Female subjects must have a negative blood pregnancy test report 3 days before dosing.
Exclusion
Exclusion Criteria:
- Pregnant or lactating women;
- Subjects with a history of cardiovascular, respiratory, liver, kidney, digestivetract, mental, neurological, hematological, immune, and metabolic abnormalities andother diseases, and not suitable for the study as assessed by the investigator;
- Subjects with clinically significant abnormalities in vital signs, physicalexamination, laboratory tests, or 12-lead ECG during the screening period;
- Have received major surgery within 3 months before screening or have surgery planduring the study;
- History of severe infection within 30 days before screening or currently experiencingsevere infection;
- The alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkalinephosphatase (ALP) are higher than the upper limit of normal (ULN);
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIVantibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);
- Glycosylated hemoglobin (HbA1c) ≥ 6.0% and fasting blood glucose ≤ 3.9 mmol/L (70mg/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 positivefor urine drug screening;
- Addicted to smoking or smokers who smoke 5 or more cigarettes per day on averagewithin 3 months before screening;
- History of alcohol abuse, or a single consumption of more than 14 units of alcohol inthe past two weeks, or positive for breath alcohol test at screening;
- Participating in any clinical trial involving drugs or medical devices within 3 monthsbefore screening;
- Blood donation or loss of ≥ 400 mL or blood transfusion within 3 months beforescreening; blood donation or loss of ≥ 200 mL within 1 month before screening;
- Subjects with severe allergic disease, or suspected allergy to any ingredient in thestudy drugs, or allergic constitution;
- Subjects with concomitant diseases that may significantly affect the absorption ofdrugs or nutrients as judged by the investigator;
- Subjects with a history of pancreatitis, and serum amylase or lipase greater than theULN;
- History or family history of medullary thyroid cancer and multiple endocrine neoplasiasyndrome type 2;
- Diet or weight loss treatment within 3 months prior to administration or having weightchange of more than 5% or significant change in living habits;
- Any medication taken within 2 weeks or 5 half-lives (whichever is longer) beforescreening and any medication expected to be taken throughout the study;
- Any physiological or psychological diseases or conditions that may increase the riskof the study, affect the subject's compliance with the protocol, or affect thesubject's completion of the study, as judged by the investigator;
- Those who should not be enrolled per the investigator's opinion.
Study Design
Total Participants: 84
Treatment Group(s): 2
Primary Treatment: HS-10501 tablet
Phase: 1
Study Start date:
March 14, 2024
Estimated Completion Date:
June 30, 2025
Connect with a study center
The second hospital of Anhui University
Hefei, Anhui 230601
ChinaActive - Recruiting
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