HealthyPhase 1NCT05531097
Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C
A Phase 1 study testing HSK31679 in people with Healthy and Elevated LDL-C, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Elevated LDL-C
- What is being tested?
- HSK31679
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesChina
- Study dates
- 22 Feb 2022to 8 Dec 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
- Additional inclusion criteria for SAD and MAD subjects who are not treated with statins: Systolic blood pressure in the range of 90 to 139 mmHg and diastolic blood pressure in the range of 60 to 89 mmHg after 5 minutes in supine position or seated.
- Additional inclusion criteria for MAD subjects who are treated with statins:
- 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.
Who cannot join
- 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.
- Laboratory tests during the screening period were abnormal and clinically significant as judged by the investigator . [The abnormal elevation of lipid related indexes in MAD patients who met the inclusion criteria and the upper limit of normal values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.0 due to long-term stable use of statins were not considered as the basis for exclusion].
- hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody test are positive at screening.
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- 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.
- Additional exclusion criteria for SAD subjects: 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.
- Additional exclusion criteria for MAD subjects:
- 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).
- Secondary dyslipidemia.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality
Xiangya Hospital of Central South University
Changsha
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses and Multiple Dose of HSK31679 in Healthy Volunteers and Subjects With Elevated LDL-C
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
- Being tested
- HSK31679, Placebo
- Keywords
- HSK31679, Healthy, Elevated LDL-C, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31679Drug
Single or multiple oral doses of HSK31679
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| HSK31679 | Experimental | Not described Receives: Drug: HSK31679 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 days after single dose and 18 days after the first dose of multiple doses
Secondary outcomes (2)
Plasma concentration of HSK31679
Assessed with or without food in single dose Assessed with or without stains in multiple doses
Measured: 0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of HSK31679
Assessed with or without stains in multiple doses
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start22 Feb 2022
- Primary completion21 Sep 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531097
- Sponsor's protocol ID
- HSK31679-101
- Status last verified
- Jan 2024
- First submitted
- 24 Aug 2022
- Last updated
- 3 Jan 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses and Multiple Dose of HSK31679 in Healthy Volunteers and Subjects With Elevated LDL-C
- ClinicalTrials.gov ID
- NCT05531097
- Acronym / sponsor ID
- HSK31679-101
- Conditions
- Healthy, Elevated LDL-C
- Keywords
- HSK31679, Healthy, Elevated LDL-C, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 7 Sep 2022 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK31679 | Experimental | Drug: HSK31679 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- Laboratory tests during the screening period were abnormal and clinically significant as judged by the investigator . [The abnormal elevation of lipid related indexes in MAD patients who met the inclusion criteria and the upper limit of normal values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.0 due to long-term stable use of statins were not considered as the basis for exclusion].
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 |
|---|---|---|
| HSK31679Single or multiple oral doses of HSK31679 | Drug | HSK31679 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs) .
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Changes from baseline in clinical laboratory parameters（Blood routine, blood biochemistry, Urine routine, Coagulation function, thyroid function and antibodies）.
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Changes from baseline in physical examination results（General condition skin mucous membrane superficial lymph nodes head neck chest abdomen spine limbs and others）.
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Changes from baseline in vital signs（Systolic and diastolic blood pressure, pulse, respiratory rate, body temperature）.
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
Changes from baseline in 12-ECG（QT interval, QTcF interval, PR interval, QRS interval and RR interval）.
Time frame: 5 days after single dose and 18 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK31679 in healthy or LDL-C elevated adult volunteers
2 secondary outcomes
Plasma concentration of HSK31679
Time frame: 0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of HSK31679
Time frame: Day 1 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK31679 in people with Healthy and Elevated LDL-C, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites 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 16 inclusion and 19 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: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment emergent adverse events (TEAEs) . (time frame: 5 days after single dose and 18 days after the first dose of multiple doses). The study lists 5 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 3 Jan 2024.