Healthy Subjects (HS)Phase 1NCT07241923
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection
A Phase 1 study testing SYH2070 injection in people with Healthy Subjects (HS), 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 SYH2070 injection when administered subcutaneously to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- SYH2070 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 1 Nov 2027
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
- Sex: Male or female;
- Age: 18-60 years (inclusive);
- Body mass index (BMI) in the range of 19 to 30 kg•m^2 [BMI = weight/height^2 (kg•m^2)] (inclusive), with a weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
- Fasting serum TG ≥150 mg/dL (1.7 mmol/L) and ≤ 500 mg/dL (5.6 mmol/L), and LDL-C ≥70 mg/dL (1.8 mmol/L) and < 190 mg/dL (4.9 mmol/L) during the screening and baseline periods;
- Subjects must maintain stable die, exercise, and other lifestyle habits from 4 weeks prior to screening until the end of the study, with no planned changes to diet, exercise or weight loss programs;
- Subjects must be able to communicate well with the investigator and can complete the study according to the protocol requirements.
Who cannot join
- History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug components (N-acetylgalactosamine, sodium hydroxide, phosphoric acid) or oligonucleotide drugs;
- Use of antibody drugs and/or oligonucleotide drugs targeting PCSK9/ANGPTL3/ApoC-III within 12 months prior to screening;
- Current and/or history of clinically significant medical conditions, including but not limited to circulatory, hematological or hematopoietic, respiratory, endocrine, urinary, digestive system diseases, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results, as judged by the investigator;
- History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study;
- History of bariatric surgery within 12 months prior to screening;
- Have clinically significant abnormalities in vital signs, physical examination, electrocardiogram, and laboratory tests (excluding lipid parameters);
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- Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m^2 at screening;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) >1.5× upper limit of normal (ULN) at screening (one retest allowed within 1 week);
- Prolonged QT / QTc interval at screening or baseline (QTcF > 450 ms);
- Positive result for any of HBsAg, HCV antibody, syphilis antibody, and HIV antibody;
- Blood loss or donation >200 mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks;
- Use of any drugs, health supplements, vitamins, or dietary supplements known to affect lipid metabolism within the longer of either: (a) 28 days prior to dosing; (b) 7 half-lives of the drug; (3) the duration of the agent's pharmacological effect, including but not limited to statins, fish oil, high-purity omega-3, prescription-dose niacin, fibrates, or anti-estrogen therapy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Trials Information Group
Shijiazhuang, Hebei
Name: Yang Lin, +86-0311-69085587, linyang@anzhengcp.com
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2070 Injection in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.
- Conditions
- Healthy Subjects (HS)
- Being tested
- SYH2070 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2070 injectionDrug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SYH2070 experimental group | Experimental | Subjects in experimental groups will receive a single subcutaneous injection of SYH2070 injection on Day 1. Receives: Drug: SYH2070 injection |
| Placebo group | Placebo comparator | Subjects in 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.
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
Measured: Pre-dose and multiple time points no less than 85 days
Secondary outcomes (7)
The serum TG level after dosing SYH2070 injection
Measured: Pre-dose and multiple timepoints no less than 85 days
The serum LDL-C level after dosing SYH2070 injection
Measured: Pre-dose and multiple timepoints no less than 85 days
Plasma Maximum concentration (Cmax)
Measured: Pre-dose and multiple timepoints up to 4 days
Time to maximum concentration (Tmax)
Measured: Pre-dose and multiple timepoints up to 4 days
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Measured: Pre-dose and multiple timepoints up to 4 days
Half-Life (t1/2)
Measured: Pre-dose and multiple timepoints up to 4 days
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Measured: Pre-dose and multiple timepoints up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies 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
- 48 participants (estimated)
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
- NCT07241923
- Sponsor's protocol ID
- SYH2070-001
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 1 Dec 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2070 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07241923
- Acronym / sponsor ID
- SYH2070-001
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Nov 2025 (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 SYH2070 injection when administered subcutaneously to healthy subjects.
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 |
|---|---|---|
| SYH2070 experimental group | Experimental | Drug: SYH2070 injectionSubjects in experimental groups will receive a single subcutaneous injection of SYH2070 injection on Day 1. |
| Placebo group | Placebo comparator | Drug: PlaceboSubjects in 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 provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
- Sex: Male or female;
- Age: 18-60 years (inclusive);
- Body mass index (BMI) in the range of 19 to 30 kg•m^2 [BMI = weight/height^2 (kg•m^2)] (inclusive), with a weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
- Fasting serum TG ≥150 mg/dL (1.7 mmol/L) and ≤ 500 mg/dL (5.6 mmol/L), and LDL-C ≥70 mg/dL (1.8 mmol/L) and < 190 mg/dL (4.9 mmol/L) during the screening and baseline periods;
Key exclusion criteria (12 listed)
- History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug components (N-acetylgalactosamine, sodium hydroxide, phosphoric acid) or oligonucleotide drugs;
- Use of antibody drugs and/or oligonucleotide drugs targeting PCSK9/ANGPTL3/ApoC-III within 12 months prior to screening;
- Current and/or history of clinically significant medical conditions, including but not limited to circulatory, hematological or hematopoietic, respiratory, endocrine, urinary, digestive system diseases, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results, as judged by the investigator;
- History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study;
- History of bariatric surgery within 12 months prior to 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 |
|---|---|---|
| SYH2070 injectionsubcutaneous injection | Drug | SYH2070 experimental group |
| Placebosubcutaneous injection | Drug | Placebo group |
Primary outcome
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
Time frame: Pre-dose and multiple time points no less than 85 days
7 secondary outcomes
The serum TG level after dosing SYH2070 injection
Time frame: Pre-dose and multiple timepoints no less than 85 days
The serum LDL-C level after dosing SYH2070 injection
Time frame: Pre-dose and multiple timepoints no less than 85 days
Plasma Maximum concentration (Cmax)
Time frame: Pre-dose and multiple timepoints up to 4 days
Time to maximum concentration (Tmax)
Time frame: Pre-dose and multiple timepoints up to 4 days
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Time frame: Pre-dose and multiple timepoints up to 4 days
Half-Life (t1/2)
Time frame: Pre-dose and multiple timepoints up to 4 days
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: Pre-dose and multiple timepoints up to 4 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 1 Dec 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.
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 SYH2070 injection in people with Healthy Subjects (HS), 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 12 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: looking for participants now, as of the sponsor's last update on 1 Dec 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?
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?
Contact Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0 (time frame: Pre-dose and multiple time points no less than 85 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 1 Dec 2025.