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 range18 Years – 60 Years
SexALL
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.
✓. 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.
What they're measuring
1
To evaluate the safety and tolerability of a single subcutaneous injection of EDP167 in adult subjects.
✕. 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.