Healthy Adult Male and Female VolunteersPhase 1NCT07412080
EDP167 in Healthy Volunteers and Subjects With Mild Dyslipidemia
A Phase 1 study testing EDP167 in people with Healthy Adult Male and Female Volunteers and Mild Dyslipidemia, run by Eddingpharm (Zhuhai) Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers, Mild Dyslipidemia
- What is being tested?
- EDP167
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 12 Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subjects who have donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to screening.
- Subjects who have participated in, or are currently participating in, another clinical trial and have received the investigational product/device or placebo within 3 months prior to screening.
- Female subjects with a positive pregnancy test at screening, or who are breastfeeding, or who plan to become pregnant during the study period.
- Any other condition that the investigator deems inappropriate for the subject to participate in this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangdong Provincial People's Hospital
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
About this study
Official title: A Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of Single Dose of EDP167 Injection in Healthy Volunteers and Subjects With Mild Dyslipidemia
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.
Read the detailed description
Angiopoietin-like 3 protein (ANGPTL3) is a key regulator of lipid metabolism. Clinical studies have shown that inhibition of ANGPTL3 could exert lipid-lowering effects in patients with dyslipidemia. EDP167 is a novel GalNAc-conjugated siRNA therapeutic that selectively silences hepatic ANGPTL3 mRNA expression, offering a promising strategy for lipid lowering. In this trial, subjects will be sequentially enrolled into five cohorts (35, 100, 200, 300 or 400 mg), each consists of six subjects receiving EDP167 and two receiving matching placebos. The follow-up will last for 85 days to evaluate the PK profile and PD effects (ANGPTL3, LDL-C, TG, and other lipid parameters) following a single subcutaneous injection of EDP167.
- Being tested
- EDP167, Placebo
- Keywords
- Dyslipidemia, ANGPTL3, siRNA
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP167Drug
EDP167 sc injection
PlaceboDrug
Sterile normal saline (0.9% NaCl) sc injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | EDP167 35mg (N=6) and Placebo (N=2) Receives: Drug: EDP167; Drug: Placebo |
| Group 2 | Experimental | EDP167 100mg (N=6) and Placebo (N=2) Receives: Drug: EDP167; Drug: Placebo |
| Group 3 | Experimental | EDP167 200mg (N=6) and Placebo (N=2) Receives: Drug: EDP167; Drug: Placebo |
| Group 4 | Experimental | EDP167 300mg (N=6) and Placebo (N=2) Receives: Drug: EDP167; Drug: Placebo |
| Group 5 | Experimental | EDP167 400mg (N=6) and Placebo (N=2) Receives: Drug: EDP167; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Concentration-time area under curve (AUC) of EDP167 in plasma
Measured: Up to 48 hours post-dose
To evaluate the time to peak concentration (Tmax) of a single subcutaneous injection of EDP167 in adult subjects.
Time to peak concentration (Tmax) of EDP167 in plasma
Measured: Up to 48 hours post-dose
To evaluate the peak concentration (Cmax) of a single subcutaneous injection of EDP167 in adult subjects.
Peak concentration (Cmax) of EDP167 in plasma
Measured: Up to 48 hours post-dose
To evaluate the apparent volume of distribution (Vd) of a single subcutaneous injection of EDP167 in adult subjects.
Measured: Up to 48 hours post-dose
To evaluate the clearance (CL) of a single subcutaneous injection of EDP167 in adult subjects.
Measured: Up to 48 hours post-dose
To evaluate the elimination half-time (t1/2) of a single subcutaneous injection of EDP167 in adult subjects.
Measured: Up to 48 hours post-dose
To evaluate the pharmacodynamic characteristics (ANGPTL3) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum ANGPTL3 level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (TG) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum TG level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (LDL-C) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum LDL-C level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (TC) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum TC level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (non-HDL-C) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum non-HDL-C level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (VLDL-C) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum VLDL-C level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (HDL-C) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum HDL-C level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (Lp(a)) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum Lp(a) level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (ApoB) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum ApoB level.
Measured: Up to 85 days post-dose
To evaluate the pharmacodynamic characteristics (ApoA-I) of a single subcutaneous injection of EDP167 in adult subjects.
Change from baseline in fasting serum ApoA-I level.
Measured: Up to 85 days post-dose
The effect of EDP167 injection on QT interval evaluated by C-QT analysis.
The difference from baseline of QTcF after administration.
Measured: Up to 48 hours post-dose
The effect of EDP167 injection on QT interval evaluated by C-QT analysis.
The correlation between drug serum concentration and QTcF.
Measured: Up to 48 hours post-dose
To evaluate the immunogenicity of EDP167.
The incidence and titer of antibodies against EDP167.
Measured: Up to 85 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jul 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eddingpharm (Zhuhai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412080
- Sponsor's protocol ID
- EDP167D101
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No