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RecruitingNCT07241923Updated Dec 1, 2025

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection

A Phase 1 interventional study of SYH2070 injection and Placebo in Healthy Subjects (HS), sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.

02

Conditions studied

  • Healthy Subjects (HS)
03

In context

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. is the lead sponsor of 26 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
  2. Sex: Male or female;
  3. Age: 18-60 years (inclusive);
  4. 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);
  5. 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;
  6. 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;
  7. Subjects must be able to communicate well with the investigator and can complete the study according to the protocol requirements.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Use of antibody drugs and/or oligonucleotide drugs targeting PCSK9/ANGPTL3/ApoC-III within 12 months prior to screening;
  3. 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;
  4. History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study;
  5. History of bariatric surgery within 12 months prior to screening;
  6. Have clinically significant abnormalities in vital signs, physical examination, electrocardiogram, and laboratory tests (excluding lipid parameters);
  7. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m\^2 at screening;
  8. 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);
  9. Prolonged QT / QTc interval at screening or baseline (QTcF > 450 ms);
  10. Positive result for any of HBsAg, HCV antibody, syphilis antibody, and HIV antibody;
  11. Blood loss or donation >200 mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks;
  12. 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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    SYH2070 experimental group

    Subjects in experimental groups will receive a single subcutaneous injection of SYH2070 injection on Day 1.

    Drug: SYH2070 injection

  • Placebo comparator
    Placebo group

    Subjects in placebo groups will receive a single subcutaneous injection of placebo on Day 1.

    Drug: Placebo

Interventions

  • DrugSYH2070 injection

    subcutaneous injection

  • DrugPlacebo

    subcutaneous injection

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. The serum TG level after dosing SYH2070 injection

    Time frame: Pre-dose and multiple timepoints no less than 85 days

  2. The serum LDL-C level after dosing SYH2070 injection

    Time frame: Pre-dose and multiple timepoints no less than 85 days

  3. Plasma Maximum concentration (Cmax)

    Time frame: Pre-dose and multiple timepoints up to 4 days

  4. Time to maximum concentration (Tmax)

    Time frame: Pre-dose and multiple timepoints up to 4 days

  5. 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

  6. Half-Life (t1/2)

    Time frame: Pre-dose and multiple timepoints up to 4 days

  7. Area under the concentration-time curve from 0 to infinity (AUC0-∞)

    Time frame: Pre-dose and multiple timepoints up to 4 days

07

Study locations

1 of 1 sites recruiting
  • Clinical Trials Information Group
    Shijiazhuang, Hebei, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07241923
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Nov 15, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Dec 1, 2025

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
+86-0311-69085587
Yang Lin
Contact
linyang@anzhengcp.com
18910778667

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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