Single ascending-dose safety and response test of SYH2070 injection in healthy adults

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 test gives a single subcutaneous dose of SYH2070 to healthy adults with mildly high triglycerides to see whether it is safe, how the body handles it, and whether it causes early biological effects compared with placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT07241923 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled single ascending dose (SAD) trial in healthy adults that will measure safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) after subcutaneous administration of SYH2070. Subjects are enrolled in sequential dose cohorts with review of safety data before escalating to the next dose. The trial enrolls adults 18–60 years with BMI 19–30 kg/m^2 and fasting triglycerides between 150 and 500 mg/dL and LDL-C between 70 and 190 mg/dL. Blood sampling for PK/PD and safety monitoring will be used to define systemic exposure and early biological effects compared with placebo.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–60 with BMI 19–30 kg/m^2, fasting triglycerides 150–500 mg/dL and LDL-C 70–190 mg/dL who can follow study procedures and remain on stable diet and activity.

Not a fit: People with normal or very low triglycerides, major medical conditions, those outside the age/BMI limits, or those seeking immediate therapeutic benefit are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify a safe single dose and early biological signals that support further development of SYH2070 for lipid management.

How similar studies have performed: Single ascending-dose randomized, double-blind, placebo-controlled Phase 1 tests are a standard first-in-human approach and commonly succeed at defining safety and PK/PD profiles, but SYH2070 itself appears novel and unproven in humans.

Eligibility criteria

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:

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;

Where this trial is running

Shijiazhuang, Hebei

• Clinical Trials Information Group — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Healthy Subjects