Actively Recruiting
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2025-12-01
48
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.
CONDITIONS
Official Title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must provide informed consent and understand study procedures and risks
- Male or female participants
- Age between 18 and 60 years inclusive
- Body mass index (BMI) between 19 and 30 kg/m² inclusive, with minimum weight of 50 kg for males and 45 kg for females
- Fasting serum triglycerides between 150 mg/dL and 500 mg/dL, and LDL-C between 70 mg/dL and less than 190 mg/dL during screening and baseline
- Stable diet, exercise, and lifestyle habits for at least 4 weeks before screening through study end
- Ability to communicate well with investigators and comply with study protocol
You will not qualify if you...
- History of severe allergic diseases or allergic constitution with three or more drug or food allergies, or known allergy to investigational drug components or oligonucleotide drugs
- Use of antibody or oligonucleotide drugs targeting PCSK9, ANGPTL3, or ApoC-III within 12 months before screening
- Current or past clinically significant medical conditions affecting various organ systems or infections, tumors, severe trauma, or other diseases interfering with study results
- History of major surgery within 6 months before screening or planned major surgery during the study
- History of bariatric surgery within 12 months before screening
- Clinically significant abnormalities in vital signs, physical exam, electrocardiogram, or laboratory tests excluding lipid parameters
- Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m² at screening
- Elevated liver enzymes or bilirubin above 1.5 times upper limit of normal at screening
- Prolonged QT/QTc interval (QTcF > 450 ms) at screening or baseline
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody
- Blood loss or donation exceeding 200 mL within 3 months before screening, excluding menstruation, or platelet donation within 2 weeks
- Use of drugs, supplements, or vitamins affecting lipid metabolism within 28 days prior to dosing or as per drug half-life or pharmacological effect
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trials Information Group
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
Y
Yang Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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