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

CSPC Pharmaceutical Group

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: Placebo; Drug: SYH2070 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07241923

SYH2070-001

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

SYH2070 experimental group

Experimental group

Description:

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

Treatment:

Drug: SYH2070 injection

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo