Healthy SubjectsPhase 1NCT06359600
A Study of HS-10501 Tablets in Healthy Subjects
A Phase 1 study testing HS-10501 tablet in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HS-10501 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Subjects with a history of pancreatitis, and serum amylase or lipase greater than the ULN;
- History or family history of medullary thyroid cancer and multiple endocrine neoplasia syndrome type 2;
- 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;
- 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;
- 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;
- Those who should not be enrolled per the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second hospital of Anhui University
Hefei, Anhui, 230601
Wei Hu, MD, 13856086475, ayefygcp@163.com
About this study
Official title: 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
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
- Being tested
- HS-10501 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10501 tabletDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single dose of HS-10501 administered orally under fasted conditions Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 2 | Experimental | Single dose of HS-10501 administered orally under fasted conditions Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 3 | Experimental | Single dose of HS-10501 administered orally under fed and fasted conditions Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 4 | Experimental | Single dose of HS-10501 administered orally under fasted conditions Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 5 | Experimental | Single dose of HS-10501 administered orally under fasted conditions Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 6 | Experimental | Single dose of HS-10501 administered orally under fasted conditions Receives: 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. Receives: Drug: HS-10501 tablet; Drug: Placebo |
| Cohort 8 | Experimental | Drugs are given once a day (QD) for 28 days. Receives: 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. Receives: Drug: HS-10501 tablet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - Cmax
Maximum observed concentration (Cmax)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - Tmax
Time to maximum observed concentration (Tmax)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - t1/2
Terminal elimination half-life (t1/2)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - CL/F
Apparent clearance (CL/F)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501- Vz/F
Apparent volume of distribution (Vz/F)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501-λz
elimination rate constant (λz)
Measured: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501- AUC0-τ
area under plasma concentration-time curve within a dosing interval
Measured: pre-dose to 72 hours post-dose
Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT)
Area under the glucose-time curve from time zero to the last quantifiable time point t (AUC0-t) after oral glucose tolerance test (OGTT)
Measured: before to 3 hours after the first intake of glucose on Day-1，Day 1 and Day 28
Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT)
Area under the insulin-time curve from time zero to the last quantifiable time point t (AUC0-t) after oral glucose tolerance test (OGTT)
Measured: before to 3 hours after the first intake of glucose on Day-1，Day 1 and Day 28
body weight changes
Change in body weight from baseline after treatment
Measured: from day-1to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start14 Mar 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359600
- Sponsor's protocol ID
- HS-10501-101
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06359600
- Acronym / sponsor ID
- HS-10501-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fasted conditions |
| Cohort 2 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fasted conditions |
| Cohort 3 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fed and fasted conditions |
| Cohort 4 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fasted conditions |
| Cohort 5 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fasted conditions |
| Cohort 6 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboSingle dose of HS-10501 administered orally under fasted conditions |
| Cohort 7 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboDrugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day. |
| Cohort 8 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboDrugs are given once a day (QD) for 28 days. |
| Cohort 9 | Experimental | Drug: HS-10501 tablet, Drug: PlaceboDrugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10501 tabletAdministered orally | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| PlaceboAdministered orally | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment.
Time frame: Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.
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.
Number of participants with clinically significant abnormalities in lab tests
Time frame: Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.
Laboratory tests include blood routine, urine routine, blood biochemistry and coagulation function, etc.
Number of participants with clinically significant change from baseline in vital signs
Time frame: Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.
Change from baseline in Electrocardiogram (ECG)
Time frame: Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.
ECG parameters including heart rate, PR interval, QRS interval and QTcF, etc.
12 secondary outcomes
Pharmacokinetic (PK) profile of HS-10501 - AUC0-t
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - Cmax
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - Tmax
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - t1/2
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501 - CL/F
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501- Vz/F
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501-λz
Time frame: pre-dose to 72 hours post-dose
Pharmacokinetic (PK) profile of HS-10501- AUC0-τ
Time frame: pre-dose to 72 hours post-dose
Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT)
Time frame: before to 3 hours after the first intake of glucose on Day-1，Day 1 and Day 28
Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT)
Time frame: before to 3 hours after the first intake of glucose on Day-1，Day 1 and Day 28
body weight changes
Time frame: from day-1to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10501 tablet in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, MD ((+86)13856086475, ayefygcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. (time frame: Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.