EDP167 in Healthy Volunteers and Subjects With Mild Dyslipidemia

NCT07412080 | Completed Phase 1 DMC

• 1 other identifier: EDP167D101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Adult Male and Female Volunteers; Mild Dyslipidemia

Keywords

Dyslipidemia; ANGPTL3; siRNA

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of a single subcutaneous injection of EDP167 in adult subjects.

  Number of participants with adverse events and serious adverse events, with clinically significant changes in vital signs, in electrocardiogram readings, in physical examination, and in laboratory tests.

  Up to 85 days post-dose

Secondary Outcomes (19)

• To evaluate the plasma concentration-time area under curve (AUC) of a single subcutaneous injection of EDP167 in adult subjects.

  Up to 48 hours post-dose

• To evaluate the time to peak concentration (Tmax) of a single subcutaneous injection of EDP167 in adult subjects.

  Up to 48 hours post-dose

• To evaluate the peak concentration (Cmax) of a single subcutaneous injection of EDP167 in adult subjects.

  Up to 48 hours post-dose

• To evaluate the apparent volume of distribution (Vd) of a single subcutaneous injection of EDP167 in adult subjects.

  Up to 48 hours post-dose

• To evaluate the clearance (CL) of a single subcutaneous injection of EDP167 in adult subjects.

  Up to 48 hours post-dose

Study Arms (5)

Group 1

EXPERIMENTAL

EDP167 35mg (N=6) and Placebo (N=2)

Drug: EDP167; Drug: Placebo

Group 2

EXPERIMENTAL

EDP167 100mg (N=6) and Placebo (N=2)

Drug: EDP167; Drug: Placebo

Group 3

EXPERIMENTAL

EDP167 200mg (N=6) and Placebo (N=2)

Drug: EDP167; Drug: Placebo

Group 4

EXPERIMENTAL

EDP167 300mg (N=6) and Placebo (N=2)

Drug: EDP167; Drug: Placebo

Group 5

EXPERIMENTAL

EDP167 400mg (N=6) and Placebo (N=2)

Drug: EDP167; Drug: Placebo

Interventions

EDP167 DRUG

EDP167 sc injection

Group 1; Group 2; Group 3; Group 4; Group 5

Placebo DRUG

Sterile normal saline (0.9% NaCl) sc injection

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who have used any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) therapy within 12 months prior to screening.
• Subjects with a history of drug abuse/substance abuse, or a positive result for the specified drugs (ketamine, marijuana, morphine, MDMA, methamphetamine, cocaine) in the urine drug screen at screening.
• Subjects who regularly consumed alcohol within 3 months prior to screening (defined as \>14 units of alcohol per week; 1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or are unwilling to abstain from alcohol during the study, or have a breath alcohol test result \>0 mg/100 mL.
• Subjects who consumed excessive amounts of tea, coffee, or caffeinated beverages (defined as \>8 cups per day; 1 cup = 250 mL) within 3 months prior to screening, or consumed any such beverages within 48 hours prior to dosing, or are unwilling to abstain from them during the study.
• Current smokers, or subjects with a positive urine nicotine test at screening, or former smokers who have quit smoking for less than 6 months.
• Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus (HIV) antibody, or specific treponemal antibody (for syphilis) at screening.
• Subjects with intolerance to venipuncture, difficulty in blood sampling, or a history of needle or blood syncope.

Sponsors & Collaborators

• Eddingpharm (Zhuhai) Co., Ltd.: lead

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: July 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

CN (2)