Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C

NCT05531097 | Completed Phase 1

• 1 other identifier: HSK31679-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I, single-dose and multiple dose escalation clinical trial for HSK31679 conducted in chinese healthy volunteers and LDL-C elevated subjects. The safety, tolerability, food-impact,pharmacokinetics and pharmacodynamics of HSK31679 tablet in healthy volunteers and LDL-C elevated volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design

Conditions

Healthy; Elevated LDL-C

Keywords

HSK31679; Healthy; Elevated LDL-C; Phase I

Outcome Measures

Primary Outcomes (5)

• The number and severity of treatment emergent adverse events (TEAEs) .

  To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers

  5 days after single dose and 18 days after the first dose of multiple doses

• Changes from baseline in clinical laboratory parameters（Blood routine, blood biochemistry, Urine routine, Coagulation function, thyroid function and antibodies）.

  To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers

  5 days after single dose and 18 days after the first dose of multiple doses

• Changes from baseline in physical examination results（General condition skin mucous membrane superficial lymph nodes head neck chest abdomen spine limbs and others）.

  To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers

  5 days after single dose and 18 days after the first dose of multiple doses

• Changes from baseline in vital signs（Systolic and diastolic blood pressure, pulse, respiratory rate, body temperature）.

  To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers

  5 days after single dose and 18 days after the first dose of multiple doses

• Changes from baseline in 12-ECG（QT interval, QTcF interval, PR interval, QRS interval and RR interval）.

  To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers

  5 days after single dose and 18 days after the first dose of multiple doses

Secondary Outcomes (2)

• Plasma concentration of HSK31679

  0 to 24 hours on Day 1 and Day 14

• Lipid level changes following administration of HSK31679

  Day 1 to Day 14

Study Arms (2)

HSK31679

EXPERIMENTAL

Drug: HSK31679

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK31679 DRUG

Single or multiple oral doses of HSK31679

HSK31679

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be willing and able to provide written informed consent.
• At the time of screening, eligibility criteria for SAD part are 18 to 55 years of age , and eligibility criteria for MAD part are 18 to 60 years of age , both male and female.
• Body mass index ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight ≥ 45 kg at Screening.
• LDL cholesterol ≥ 70mg/dL for SAD part and LDL cholesterol ≥ 100mg/dL for MAD part.
• Triglyceride \<400 mg/dL.
• Medically healthy without clinically significant abnormalities at Screening and predose on Day 1, including:
• Physical examination without any clinically relevant findings.
• Heart rate in the range of 50 to 100 bpm after 5 minutes rest in supine position or seated.
• Body temperature, between 35.0°C and 37.7°C.
• Three conventional 12-ECG recordings (the average of the three measurements will be used to determine eligibility) were consistent with normal cardiac conduction and function.
• Fertile male and female subjects agree to use appropriate physical contraception during the study and for 6 months after the last dose.
• Willing and able to comply with all study evaluations and adhere to protocol schedules and constraints.
• Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 60 to 100 mmHg after 5 minutes in supine position or seated.
• A stable dose of a statin (simvastatin atorvastatin or rosuvastatin) is administered daily for 28 days before randomization.

You may not qualify if:

• history or presence of major diseases of the cardiovascular, respiratory, digestive, urological, hematologic, endocrine, immunologic, skin or nervous system, as well as any acute illness or surgical procedure within the past 3 months as determined by the investigator to be clinically relevant. Any clinically significant uncontrolled endocrine or immune disease known to affect lipid or lipoprotein levels.
• Current infection requiring treatment with antibiotics, antifungal, antiparasitic, or antiviral agents.
• Any history of malignancy within the last 10 years.
• Previous thyroid related disease and/or abnormal thyroid function tests during screening are clinically significant.
• hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody test are positive at screening.
• Have gastrointestinal, liver, kidney, or other diseases known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• History of drug abuse in the 12 months prior to the first administration of the study drug or alcohol abuse in the 3 months prior.
• A clinically significant allergic reaction that the investigator believes interferes with the subject's ability to participate in the trial; Known allergies to any of the study drug ingredients.
• Any live vaccine was administered within 30 days prior to the first administration of the study drug.
• Pregnant or lactating women.
• Donate blood or plasma within 3 months prior to the first administration of the study drug, or lose more than 500mL of whole blood, or receive blood transfusion within 1 year prior to the first administration of the study drug.
• History of Participating in another investigational clinical trial within 90 days before the first administration of the study drug.
• Any other factors considered by the investigator to be inappropriate for participation in the trial.
• Use of any prescription and over-the-counter drugs during the 14 days prior to the first administration of the study drug or during the 5 half-lives of the drug, whichever is longer, unless deemed by both the investigator and the sponsor to be of no clinical relevance and not to affect lipid levels.Blood pressure medications (up to 2 blood pressure medications per subject) are permitted, and subjects who are treated with statins are allowed to take a stable dose of simvastatin, atorvastatin or rosuvastatin according to the protocol.
• Patients with homozygous familial hypercholesterolemia (HoFH).

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 7, 2022
• Study Start: February 22, 2022
• Primary Completion: September 21, 2022
• Study Completion: December 8, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

CN (2)