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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10510 in Healthy Subjects

ConditionDyslipidemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.

This study will consist of three parts (Parts A，B and C). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male and female subjects aged 18-55 years (inclusive) at the time of signing the informed consent form.

Agree to use highly effective contraception from the date of signing the informed consent to 30 days after the last dose.

Male or female subjects agree to avoid donating sperm or eggs from the date of signing the informed consent to 90 days after the last dose.

Female subjects of childbearing potential must have a negative blood pregnancy test within 3 days before dosing.

Disqualifiers

Subjects with clinically significant abnormalities in vital signs, physical examination, or laboratory test results during the screening period, as determined by the investigator (a single retest may be performed within the screening window if there is a clear reason for retesting, and the retest results will be used for screening).

Subjects who have undergone LDL apheresis or plasmapheresis within 12 months before screening.

Subjects who have donated or lost ≥400 mL of blood or received a blood transfusion or bone marrow donation within 3 months before screening; or donated or lost ≥200 mL of blood within 1 month before screening.

Subjects with clinically significant abnormalities in 12-lead ECG results at screening, as determined by the investigator (e.g., QTcF interval (Fridericia's formula) >450 msec for males, >470 msec for females; PR interval >200 msec, etc.).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Drug：HS-10510；

    Drug

    Drug：HS-10510 Description：Subjects will receive HS-10510 orally as a single and multiple ascending dose.

  • Drug：Placebo

    Drug

    Drug：Placebo Description：Subjects will receive placebo matching the HS-10510 dose orally as a single and multiple ascending dose.

  • Drug： Rosuvastatin

    Drug

    Drug：Rosuvastatin Description：Subjects will receive rosuvastatin orally.

Treatment groups

88 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A-HS-10510 dose 1/placeboActive comparator 2 interventions
Group B: Part A-HS-10510 dose 2/placeboActive comparator 2 interventions
Group C: Part A-S-10510 dose 3/placeboActive comparator 2 interventions
Group D: Part A-HS-10510 dose 4/placeboActive comparator 2 interventions
Group E: Part B-HS-10510 dose 1/placeboActive comparator 2 interventions
Group F: Part B-HS-10510 dose 2/placeboActive comparator 2 interventions
Group G: Part B-HS-10510 dose 3/placeboActive comparator 2 interventions
Group H: Part C-HS-10510/Placebo with rosuvastatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Number of subjects with Adverse Events

The safety and tolerability of HS-10510 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.

Time frame
From Screening until Follow-up Visit (7 days post-dose for all cohorts)

Secondary outcomes

1

LDL-C

The pharmacodynamics (PD) of HS-10510 by assessment of LDL-C following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.

Time frame
SAD cohorts: Days 1,2,3,4,8 Food Effect SAD cohort: Day 1,2,3,4,8,9,10,11,15 MAD cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35 Rosuvastatin MAD Cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35
2

Proprotein convertase subtilisin/kexin type 9(PCSK9)

The PD of HS-10510 by assessment of PCSK9 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.

Time frame
SAD cohorts: Days 1,2,3,8 Food Effect SAD cohort: Day 1,2,3,8,9,10,15 MAD cohorts: Days 1,2,3,7,11,15,22,28,31,35 Rosuvastatin MAD Cohorts: Days 1,2,3,7,11,15,22,28,31,35
3

HS-10510 PK parameter: Maximum observed plasma concentration (Cmax)

To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.

Time frame
SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
4

HS-10510 PK parameter: Area under plasma concentration-time curve from zero to infinity (AUC0-inf)

To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.

Time frame
SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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