A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: +86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Contact Backup
- Name: Yang Lin
- Phone Number: 18910778667
- Email: linyang@anzhengcp.com
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Recruiting
- Clinical Trials Information Group
-
Contact:
- Name: Yang Lin
- Phone Number: +86-0311-69085587
- Email: linyang@anzhengcp.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: SYH2070 experimental group
Subjects in experimental groups will receive a single subcutaneous injection of SYH2070 injection on Day 1.
|
subcutaneous injection
|
|
Placebo Comparator: Placebo group
Subjects in placebo groups will receive a single subcutaneous injection of placebo on Day 1.
|
subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Pre-dose and multiple time points no less than 85 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The serum TG level after dosing SYH2070 injection
Time Frame: Pre-dose and multiple timepoints no less than 85 days
|
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
|
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
|
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
|
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
|
Pre-dose and multiple timepoints up to 4 days
|
|
Half-Life (t1/2)
Time Frame: Pre-dose and multiple timepoints up to 4 days
|
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
|
Pre-dose and multiple timepoints up to 4 days
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- SYH2070-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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