HealthyPhase 1NCT05742126
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dosed of HSK36273 in Healthy Volunteers
A Phase 1 study testing HSK36273 and Heparin sodium injection in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, Phase 1, placebo and positive-controlled, randomized, partial-blind, integrated, sequential ascending dose / multiple ascending dose study.The safety, tolerability, pharmacokinetics and pharmacodynamics of multiple continuous IV infusion ascending doses of HSK36273 in healthy volunteers will… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HSK36273 and Heparin sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2022to 15 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and females, 18 to 45 years of age (inclusive) at Screening.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m2 and a weight of at least 45 kg for female and 50 kg for male.
- The subject must be willing and able to provide written informed consent
- Medically healthy without clinically significant abnormalities at Screening and predose on Day 1, including:
- Physical examination without any clinically relevant findings.
- 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.
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- QT interval corrected using the Fridericia method (QTcF) between 350 to 450 msec for male subjects and 350 to 470 msec for female subjects, inclusive.
- Normal laboratory tests (hematology, biochemistry, urinalysis, coagulation tests (aPTT and PT).
- No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as deemed by the Investigator.
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Willing and able to comply with all study evaluations and adhere to protocol schedules and constraints.
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.
- History of abnormal bleeding episodes, e.g. nosebleeds, or abnormally heavy periods, or extensive bleeding after injury, surgery or dental work within 3 months prior to screening.
- Any clinically Laboratory tests during the screening period were abnormal and clinically significant as judged by the investigator. Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase[GGT]) and total bilirubin elevated above the ULN.
- Positive test results for active HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies (Abs).
- Hemoglobin or hematocrit clinically significantly less than lower limits of normal at screening.
- 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.
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- 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, allergy to anticoagulants or antiplatelet drugs or obvious adverse reactions, allergic to two or more drugs or food, allergic to any ingredient in this product and auxiliary materials.
- Donate blood or plasma within 3 months prior to the first administration of the study drug, or lose more than 400mL 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.
- Poor venous access that would hamper a 5-day infusion.
- Positive pregnancy test at screening or check-in (Day -1).
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics), or five (5) half-lives, whichever is longer, prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Any other factors considered by the investigator to be inappropriate for participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: A Randomized, Partial-Blind, Placebo and Positive-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HSK36273 in Healthy Subjects.
This is a single-center, Phase 1, placebo and positive-controlled, randomized, partial-blind, integrated, sequential ascending dose / multiple ascending dose study.The safety, tolerability, pharmacokinetics and pharmacodynamics of multiple continuous IV infusion ascending doses of HSK36273 in healthy volunteers will be evaluated.
- Conditions
- Healthy
- Being tested
- HSK36273, Placebo, Heparin sodium injection
- Keywords
- HSK36273, healthy, Phase I, continuous IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK36273Drug
Multiple continuous IV infusion ascending doses for 5 days
PlaceboDrug
Matching placebo
Heparin sodium injectionDrug
Matching positive control
| Study group | Role | What they receive |
|---|---|---|
| HSK36273 | Experimental | Multiple continuous IV infusion ascending doses in cohort 1-5 Receives: Drug: HSK36273 |
| Placebo | Placebo comparator | 5 cohorts with matching placebo to HSK36273 Receives: Drug: Placebo |
| Heparin sodium injection | Active comparator | Cohort 1-2 with matching positive control to HSK36273 Receives: Drug: Heparin sodium injection |
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 multiple of HSK36273 following 24-hour continuous IV infusions administered over 5 consecutive days with ascending doses in healthy subjects
Measured: Day1 to Day8
Secondary outcomes (11)
AUC0-24h
Area under the drug concentration-time curve, from time 0h to 24h
Measured: within 1 hour before administration until 24 hours after starting administration
AUC0-144h
Area under the drug concentration-time curve, from time 0h to 144h
Measured: within 1 hour before administration until 144 hours after administration
Css
Steady-State Concentration with a the Initiation of Continuous IV 5-day Infusion of HSK36273
Measured: within 1 hour before administration until 144 hours after administration
Tss
Time to Reach a Steady-State Concentration Following a the Initiation of Continuous IV 5-day Infusion of HSK36273
Measured: within 1 hour before administration until 144 hours after administration
t1/2
Apparent terminal half-life
Measured: 24 hours after administration
CL
Apparent total clearance of drug
Measured: 24 hours after administration
Vd
Apparent volume of distribution
Measured: 24 hours after administration
Activated Partial Thromboplastin Time (aPTT)
Clotting Biomarker Activated Partial Thromboplastin Time During the Course of a Continuous IV 5-day Infusion of HSK36273
Measured: within 1 hour before administration until 144 hours after administration
Prothrombin Time (PT)
Clotting Biomarker Prothrombin During the Course of a Continuous IV 5-day Infusion of HSK36273
Measured: within 1 hour before administration until 144 hours after administration
Activated Clotting Time (ACT)
Clotting Biomarker Activated Clotting Time During the Course of a Continuous IV 5-day Infusion of HSK36273
Measured: within 1 hour before administration until 144 hours after administration
FXIa
Change from baseline in factor XI activity
Measured: within 1 hour before administration until 144 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start11 Apr 2022
- Primary completion12 Sep 2022
- Study completion15 Sep 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
- 54 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
- NCT05742126
- Sponsor's protocol ID
- HSK36273-101
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partial-Blind, Placebo and Positive-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HSK36273 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05742126
- Acronym / sponsor ID
- HSK36273-101
- Conditions
- Healthy
- Keywords
- HSK36273, healthy, Phase I, continuous IV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 23 Feb 2023 (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 single-center, Phase 1, placebo and positive-controlled, randomized, partial-blind, integrated, sequential ascending dose / multiple ascending dose study.The safety, tolerability, pharmacokinetics and pharmacodynamics of multiple continuous IV infusion ascending doses of HSK36273 in healthy volunteers will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK36273 | Experimental | Drug: HSK36273Multiple continuous IV infusion ascending doses in cohort 1-5 |
| Placebo | Placebo comparator | Drug: Placebo5 cohorts with matching placebo to HSK36273 |
| Heparin sodium injection | Active comparator | Drug: Heparin sodium injectionCohort 1-2 with matching positive control to HSK36273 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Adult males and females, 18 to 45 years of age (inclusive) at Screening.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m2 and a weight of at least 45 kg for female and 50 kg for male.
- The subject must be willing and able to provide written informed consent
- Medically healthy without clinically significant abnormalities at Screening and predose on Day 1, including:
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Key exclusion criteria (13 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.
- History of abnormal bleeding episodes, e.g. nosebleeds, or abnormally heavy periods, or extensive bleeding after injury, surgery or dental work within 3 months prior to screening.
- Any clinically Laboratory tests during the screening period were abnormal and clinically significant as judged by the investigator. Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase[GGT]) and total bilirubin elevated above the ULN.
- Positive test results for active HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies (Abs).
- Hemoglobin or hematocrit clinically significantly less than lower limits of normal at screening.
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 |
|---|---|---|
| HSK36273Multiple continuous IV infusion ascending doses for 5 days | Drug | HSK36273 |
| PlaceboMatching placebo | Drug | Placebo |
| Heparin sodium injectionMatching positive control | Drug | Heparin sodium injection |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs) .
Time frame: Day1 to Day8
To assess the safety and tolerability of multiple of HSK36273 following 24-hour continuous IV infusions administered over 5 consecutive days with ascending doses in healthy subjects
11 secondary outcomes
AUC0-24h
Time frame: within 1 hour before administration until 24 hours after starting administration
AUC0-144h
Time frame: within 1 hour before administration until 144 hours after administration
Css
Time frame: within 1 hour before administration until 144 hours after administration
Tss
Time frame: within 1 hour before administration until 144 hours after administration
t1/2
Time frame: 24 hours after administration
CL
Time frame: 24 hours after administration
Vd
Time frame: 24 hours after administration
Activated Partial Thromboplastin Time (aPTT)
Time frame: within 1 hour before administration until 144 hours after administration
Prothrombin Time (PT)
Time frame: within 1 hour before administration until 144 hours after administration
Activated Clotting Time (ACT)
Time frame: within 1 hour before administration until 144 hours after administration
FXIa
Time frame: within 1 hour before administration until 144 hours after administration
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 23 Feb 2023.
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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.
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 HSK36273 and Heparin sodium injection in people with Healthy, run by Haisco Pharmaceutical Group 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 11 inclusion and 13 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 23 Feb 2023. 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. 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: Day1 to Day8). 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 23 Feb 2023.