HyperlipemiaPhase 1NCT06229548
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053
A Phase 1 study testing SYH2053 in people with Hyperlipemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- SYH2053
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 25 Mar 2025
- 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
- Subjects must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.
- Sex: male or female subjects.
- Age of 18 - 60 years (inclusive).
- BMI: 18.6-28.5 kg/m^2 (inclusive), with a minimum weight of 50 kg (inclusive) for male and 45 kg (inclusive) for female.
- During screening and baseline, LDL-C ≥100 mg/dL (2.6 mmol/L) and < 190 mg/dL (4.9 mmol/L); TG ≤ 400 mg/dL (4.5 mmol/L); TC < 278 mg/dL (7.2 mmol/L) in serum under fasting state;
- Subjects have no history of chronic or serious diseases or family history of early-onset coronary heart disease, including cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, psychiatric, neurological, and gastrointestinal systems, and are generally in good health.
- The subjects can communicate well with the investigators and complete the trial according to the protocol.
Who cannot join
- Allergic constitution or known history of allergy to the components of the study drug or similar drugs.
- Antibody drugs targeting PCSK9 have been used within 6 months prior to screening, oligonucleotides targeting PCSK9 have been used within 12 months prior to screening.
- There are currently medical disorders of clinical significance, including but not limited to, circulatory, hematological or hematopoietic diseases, respiratory, endocrine, urinary, digestive, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other diseases that the investigator considers to be excluded or likely to interfere with the interpretation of the findings.
- Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
- Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory examination.
- The estimated glomerular filtration rate (eGFR) during screening was < 90 mL/min/1.73 m^2 (calculated by simplified MDRD formula).
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- During screening, any item of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), γ-glutamyltransferase (GGT), alkaline phosphatase (ALP) > 1.5×ULN (retest once within 1 week allowed).
- During screening or baseline, subjects with prolonged QT/QTc interval (QTcF > 450 ms in male, > 470 ms in female).
- Subjects with non-negative test for any of HBsAg, HCV antibodies, syphilis antibodies, and HIV antibodies.
- Blood loss or blood donation of more than 200 mL within 3 months prior to administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to administration.
- Use of any drug, supplement, vitamin or dietary supplement known to affect lipid metabolism within 28 days prior to administration; use of any drug for therapeutic purposes (except topical drugs with local effects) within 14 days prior to administration or within the 7 half-lives of the drug (whichever is longer).
- A history of drug abuse, and/or drug use within 3 months prior to screening, and/or habitual use of any psychotropic drug, including Chinese herbs.
- Positive urine drug screening.
Trial locations and contacts
1 site in 1 country.
China1 site
10 Chedaogou Rd.,Haidian District, Beijing, China
Beijing, Beijing Municipality
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2053 in Subjects With Normal or Elevated Low-Density Lipoprotein Cholesterol
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.
- Conditions
- Hyperlipemia
- Being tested
- SYH2053, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2053Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SYH2053 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH2053 on Day 1. Receives: Drug: SYH2053 |
| Placebo SAD group | Placebo comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
Measured: Pre-dose and multiple timepoints no less than 57 days
Secondary outcomes (16)
The serum LDL-C level after dosing SYH2053
measure the LDL-C level in blood by lab examination and evaluate the effect of SYH2053 on LDL-C Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum PCSK9 level after dosing SYH2053
measure the PCSK9 level in blood by lab examination and evaluate the effect of SYH2053 on PCSK9 Level
Measured: Pre-dose and multiple timepoints no less than 57 days
PK parameters (Cmax)
maximum peak observed plasma SYH2053 concentration in treated subjects
Measured: Pre-dose and multiple timepoints up to 4 days
PK parameters (Tmax)
time to reach maximum peak plasma SYH2053 concentration in treated subjects
Measured: Pre-dose and multiple timepoints up to 4 days
PK parameters (AUC)
area under the plasma concentration-time curve in SYH2053 treated subjects
Measured: Pre-dose and multiple timepoints up to 4 days
PK parameters (T1/2)
the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in SYH2053 treated subjects
Measured: Pre-dose and multiple timepoints up to 4 days
Immunogenicity of SYH2053
Rate of formation of anti-drug antibodies to SYH2053
Measured: Pre-dose and multiple timepoints up to 57 days
The serum TC level after dosing SYH2053
measure the TC level in blood by lab examination and evaluate the effect of SYH2053 on TC Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum TG level after dosing SYH2053
measure the TG level in blood by lab examination and evaluate the effect of SYH2053 on TG Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum HDL-C level after dosing SYH2053
measure the HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on HDL-C Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum Lp(a) level after dosing SYH2053
measure the Lp(a) level in blood by lab examination and evaluate the effect of SYH2053 on Lp(a) Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum VLDL-C level after dosing SYH2053
measure the VLDL-C level in blood by lab examination and evaluate the effect of SYH2053 on VLDL-C Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum non-HDL-C level after dosing SYH2053
measure the non-HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on non-HDL-C Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum ApoA1 level after dosing SYH2053
measure the ApoA1 level in blood by lab examination and evaluate the effect of SYH2053 on ApoA1 Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum ApoB level after dosing SYH2053
measure the ApoB level in blood by lab examination and evaluate the effect of SYH2053 on ApoB Level
Measured: Pre-dose and multiple timepoints no less than 57 days
The serum hsCRP level after dosing SYH2053
measure the hsCRP level in blood by lab examination and evaluate the effect of SYH2053 on hsCRP Level
Measured: Pre-dose and multiple timepoints no less than 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Jan 2024
- Primary completion23 Dec 2024
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipemiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229548
- Sponsor's protocol ID
- SYH2053-001
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 4 Apr 2025
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2053 in Subjects With Normal or Elevated Low-Density Lipoprotein Cholesterol
- ClinicalTrials.gov ID
- NCT06229548
- Acronym / sponsor ID
- SYH2053-001
- Conditions
- Hyperlipemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 29 Jan 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 randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYH2053 SAD experimental group | Experimental | Drug: SYH2053Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH2053 on Day 1. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboSubjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.
- Sex: male or female subjects.
- Age of 18 - 60 years (inclusive).
- BMI: 18.6-28.5 kg/m^2 (inclusive), with a minimum weight of 50 kg (inclusive) for male and 45 kg (inclusive) for female.
- During screening and baseline, LDL-C ≥100 mg/dL (2.6 mmol/L) and < 190 mg/dL (4.9 mmol/L); TG ≤ 400 mg/dL (4.5 mmol/L); TC < 278 mg/dL (7.2 mmol/L) in serum under fasting state;
Key exclusion criteria (13 listed)
- Allergic constitution or known history of allergy to the components of the study drug or similar drugs.
- Antibody drugs targeting PCSK9 have been used within 6 months prior to screening, oligonucleotides targeting PCSK9 have been used within 12 months prior to screening.
- There are currently medical disorders of clinical significance, including but not limited to, circulatory, hematological or hematopoietic diseases, respiratory, endocrine, urinary, digestive, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other diseases that the investigator considers to be excluded or likely to interfere with the interpretation of the findings.
- Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
- Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory examination.
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 |
|---|---|---|
| SYH2053subcutaneous injection | Drug | SYH2053 SAD experimental group |
| Placebosubcutaneous injection | Drug | Placebo SAD group |
Primary outcome
The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Pre-dose and multiple timepoints no less than 57 days
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
16 secondary outcomes
The serum LDL-C level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum PCSK9 level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
PK parameters (Cmax)
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (Tmax)
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (AUC)
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (T1/2)
Time frame: Pre-dose and multiple timepoints up to 4 days
Immunogenicity of SYH2053
Time frame: Pre-dose and multiple timepoints up to 57 days
The serum TC level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum TG level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum HDL-C level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum Lp(a) level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum VLDL-C level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum non-HDL-C level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum ApoA1 level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum ApoB level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum hsCRP level after dosing SYH2053
Time frame: Pre-dose and multiple timepoints no less than 57 days
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 4 Apr 2025.
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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 SYH2053 in people with Hyperlipemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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 7 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 4 Apr 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. 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 of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 (time frame: Pre-dose and multiple timepoints no less than 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 4 Apr 2025.