HypercholesterolemiaPhase 1NCT06504043
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
A Phase 1 study testing HST101 in people with Hypercholesterolemia and Healthy Volunteers, run by Hasten Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol
- What is being tested?
- HST101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels;
- LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening;
- Body mass index (BMI) ≥18 and≤28 kg/m2
Who cannot join
- Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody;
- Clinically significant liver function test abnormalities at screening, such as AST or ALT > 2 × ULN, total bilirubin > 1.5 × ULN, or ALP > 2 × ULN based on normal values;
- CK > 3 × ULN at the screening visit, it can be retested if considered to be related to exercise;
- History of prescription drug abuse, illicit drug use or alcohol abuse;
- Use of any prescription drug, herbal and compound decoction, vitamins, minerals, and OTC drugs and nutritional supplements that alter lipid metabolism within 14 days prior to Check-in and planned use of the above drugs throughout the study;
- Prior treatment with PCSK9 inhibitors, including mAbs, siRNA products, or any Adnectin products;
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- History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine;
- Less than 30 days or less than 5 half-lives (drug) since the end of participation in another clinical trial (drug or device), whichever is longer;
- Use of any other biologics within 3 months prior to investigational product administration;
- Any other significant clinical diseases or psychological diseases that the investigator considers to be inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.
Read the detailed description
The planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the HST101 group or the matching dose placebo group and will be administered in subsequent or in-parallel manner. Cohort 1: 15 study participants will receive the low dose of HST101 or placebo at a corresponding dose. Cohort 2: additional 15 study participants will receive the high dose of HST101 or placebo at a corresponding dose.
- Conditions
- Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol
- Being tested
- HST101
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HST101Drug
Also called Lerodalcibep
HST101 is a novel anti-PCSK9 fusion protein
| Study group | Role | What they receive |
|---|---|---|
| Experimental: cohort low dose HST101 | Experimental | HST101 single SC administration of 150 mg or placebo; Receives: Drug: HST101 |
| Experimental: cohort high dose HST101 | Experimental | HST101 single SC administration of 300 mg or placebo. Receives: Drug: HST101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L)
Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
Measured: 57 days
Secondary outcomes (7)
To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose
The PK parameters include Cmax, Tmax, T1/2, AUC0-t, AUCinf and others if necessary
Measured: 57 days
To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations
Serum free PCSK9 and LDL-C will be measured at baseline and various time points over 57 days
Measured: 57 days
To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG
Serum TC,HDL-C,VLDL-C and TG（ISU:mmol/L）will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
Measured: 57 days
To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations
Serum Apo B(ISU:mg/dL) , Apo A1(ISU:mg/dL) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
Measured: 57 days
To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations
Serum Lp (a)(ISU: nmol/L) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
Measured: 57 days
To assess the PK-PD relationship following a single SC dose of HST101
The PK-PD relationship will be measured over 57 days
Measured: 57 days
To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101
Measurement of ADAs/NAbs will be done at baseline and various intervals after HST101 administration
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start17 Sep 2024
- Primary completion8 Jan 2025
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Model description
- the initially enrolled 15 subjects will receive low-dose single SC administration, followed by another 15 subjects will receive high-dose single SC administration.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504043
- Sponsor's protocol ID
- HST101-101
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels
- ClinicalTrials.gov ID
- NCT06504043
- Acronym / sponsor ID
- HST101-101
- Conditions
- Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Jul 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.
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.
Detailed description
The planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the HST101 group or the matching dose placebo group and will be administered in subsequent or in-parallel manner. Cohort 1: 15 study participants will receive the low dose of HST101 or placebo at a corresponding dose. Cohort 2: additional 15 study participants will receive the high dose of HST101 or placebo at a corresponding dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the initially enrolled 15 subjects will receive low-dose single SC administration, followed by another 15 subjects will receive high-dose single SC administration.
| Arm | Type | Receives |
|---|---|---|
| Experimental: cohort low dose HST101 | Experimental | Drug: HST101HST101 single SC administration of 150 mg or placebo; |
| Experimental: cohort high dose HST101 | Experimental | Drug: HST101HST101 single SC administration of 300 mg or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels;
- LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening;
- Body mass index (BMI) ≥18 and≤28 kg/m2
Key exclusion criteria (10 listed)
- Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody;
- Clinically significant liver function test abnormalities at screening, such as AST or ALT > 2 × ULN, total bilirubin > 1.5 × ULN, or ALP > 2 × ULN based on normal values;
- CK > 3 × ULN at the screening visit, it can be retested if considered to be related to exercise;
- History of prescription drug abuse, illicit drug use or alcohol abuse;
- Use of any prescription drug, herbal and compound decoction, vitamins, minerals, and OTC drugs and nutritional supplements that alter lipid metabolism within 14 days prior to Check-in and planned use of the above drugs throughout the study;
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 |
|---|---|---|
| HST101Also: LerodalcibepHST101 is a novel anti-PCSK9 fusion protein | Drug | Experimental: cohort high dose HST101, Experimental: cohort low dose HST101 |
Primary outcome
The primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L)
Time frame: 57 days
Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
7 secondary outcomes
To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose
Time frame: 57 days
To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations
Time frame: 57 days
To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG
Time frame: 57 days
To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations
Time frame: 57 days
To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations
Time frame: 57 days
To assess the PK-PD relationship following a single SC dose of HST101
Time frame: 57 days
To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101
Time frame: 57 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 HST101 in people with Hypercholesterolemia and Healthy Volunteers, run by Hasten Biopharmaceutical 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 3 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 14 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L) (time frame: 57 days). 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 14 Mar 2025.