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Tests treatment safety and results for Healthy Subjects (HS)
Official title A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection
ClinicalTrials.gov ID: NCT07241923
What this study is testing
What is SYH2070 injection?
SYH2070 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy subjects (hs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- people must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily...
- 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...
- 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...
You likely can't join if
- History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug...
- 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...
- 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);
See the full eligibility criteria
- people 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;
- people 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;
- people must be able to communicate well with the investigator and can complete the study according to the protocol requirements.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.