EDP167 in Healthy Volunteers and Subjects With Mild Dyslipidemia (NCT07412080) | Clinical Trial Compass
CompletedPhase 1
EDP167 in Healthy Volunteers and Subjects With Mild Dyslipidemia
China40 participantsStarted 2025-07-01
Plain-language summary
EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting ANGPTL3, which may bring benefits for patients with dyslipidemia conditions. This is the first in human study of EDP167 in health volunteers and subjects with mild dyslipidemia to evaluate the safety and PK/PD profiles of EDP167.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects aged 18 to 60 years (inclusive) at the time of signing the informed consent form, male or female.
. Male subjects weighing ≥50.0 kg, female subjects weighing ≥45.0 kg, and body mass index (BMI) between 18.0 and 35.0 kg/m² (inclusive).
. Subjects with fasting serum TG ≥1.13 mmol/L and \<5.6 mmol/L, and LDL-C ≥1.8 mmol/L and \<4.9 mmol/L at screening.
. Subjects with no abnormalities or only minor abnormalities judged by the investigator as clinically insignificant (excluding lipid laboratory tests) upon physical examination, vital signs, 12-lead ECG, posteroanterior and lateral chest X-rays, abdominal ultrasound, and laboratory tests at screening.
. Subjects who have maintained a stable dietary habit for at least 4 weeks before dose administration, and have no plans to significantly change their diet or body weight during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of a single subcutaneous injection of EDP167 in adult subjects.
. Female subjects of childbearing potential or male subjects with partners of childbearing potential must agree to use highly effective contraception from signing the informed consent form until 6 months after dosing and refrain from donating sperm or eggs.
. Subjects who voluntarily sign the written informed consent form, understand the study procedures and content, are able to communicate well with the investigator, and are willing to comply with the relevant study regulations.
Exclusion criteria
. Subjects with known allergy/hypersensitivity to the investigational drug, its components, or drugs of the same class.
. Subjects with a history or current presence of serious or clinically significant diseases/abnormalities, including but not limited to cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, biliary, dermatologic, hematologic, immunologic, neurologic, or psychiatric diseases/abnormalities, , or any diseases (except for dyslipidemia) that the investigator considers to pose safety concerns or interfere with the pharmacokinetic evaluation.
. Subjects who have undergone major surgery within 3 months prior to screening, or have undergone surgery that may significantly affect drug absorption, distribution, metabolism, or excretion, or who plan to undergo elective surgery during the study.
. Subjects with any of the following laboratory abnormalities at screening: total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) \>1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN.
. Subjects with any of the following 12-lead ECG findings: QTcF \>450 ms or any other clinically significant abnormal ECG result.
. Subjects with tattoos, scars, or birthmarks on the abdomen, upper arms, or thighs that may interfere with the assessment of injection site reactions.
. Subjects who have used any prescription drugs, over-the-counter (OTC) medications, Chinese herbal medicines, or health supplements within 14 days prior to dosing; or for whom administration occurs within 5 half-lives of any prior medication (based on the longer period); or who have used any medication known to affect lipid metabolism within 90 days prior to screening.
. Subjects who have received any live vaccine within 4 weeks prior to screening, or who plan to receive any live vaccine during the study.