Actively Recruiting
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered COR-1004
Led by Corsera Health · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new injectable drug called COR-1004 for adults with high LDL cholesterol (100 mg/dL or higher) who are otherwise healthy and not taking cholesterol-lowering medicines. This early-phase study aims to find out if COR-1004 is safe, determine the highest dose without serious side effects, understand how the body processes the drug, and observe its effects on "bad" cholesterol levels. The information will help decide if larger studies are needed in the future. Participants will receive a single subcutaneous injection of COR-1004 or a placebo in groups of ten. Most participants in each group will get the study drug, while a few will receive a placebo to help understand the drug's true effects. The study uses a randomized, double-blind design and tests increasing dose levels, starting with a low dose. The first two people in each new dose group will be monitored for 24 hours before others receive the injection to ensure safety. After the injection, participants will visit the clinic multiple times over one year for health checks, physical exams, and blood tests to monitor safety and cholesterol levels. Experts will oversee the study to protect participants. Researchers will track any side effects, drug behavior in the body, and changes in cholesterol. Participants' involvement lasts about 12 months, including follow-up and safety monitoring.
CONDITIONS
Brief Title
A Study to Evaluate COR-1004 in Adult Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Serum LDL-C 100 mg/dL at screening
- Female participants of childbearing potential must agree to use two highly effective contraception methods, including a barrier method
- Post-menopausal females must be post-menopausal for at least 12 months
- Male participants and their partners of childbearing potential must agree to use two highly effective contraception methods, including a barrier method, for 90 days after drug administration
- Able and willing to provide written informed consent and comply with study requirements
- Generally healthy adults aged 18 to 65 years
You will not qualify if you...
- Any active or chronic disease
- Active or history of serious mental illness or psychiatric disorder
- Clinically significant illness within 7 days before drug administration
- Risk of atherosclerotic cardiovascular disease 7.5% based on ASCVD Risk Estimator Plus
- Fasting triglyceride level 400 mg/dL
- Significant abnormalities in physical exam, vital signs, or labs (except LDL-C) during screening
- Risk factors or family history for QT or QTcF prolongation or ECG abnormalities
- Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at screening or before dosing
- Resting pulse rate <40 bpm or >90 bpm at screening
- Abnormal kidney function or creatinine clearance <60 mL/min
- Elevated liver enzymes or abnormal coagulation tests at screening
- Positive test for hepatitis B, hepatitis C, or HIV infection
- Pregnant or lactating women, or males with pregnant or lactating partners
- History of multiple drug allergies or allergic reaction to oligonucleotides, GalNAc, or inclisiran
- Participation in another investigational drug or device study within specified timeframes
- Prior use of siRNA products
- Use of medications or supplements that affect serum lipids within 30 days before screening, except limited exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single subcutaneous dose of COR-1004 or placebo and are monitored closely for safety and tolerability.
1 dosing visit (in-person)
Duration - Up to 90 days
Participants return to the clinical site for safety, pharmacokinetics, pharmacodynamics, and exploratory biomarker monitoring on an outpatient basis through Day 90.
Multiple outpatient visits through Day 90
Duration - Up to 12 months
Participants continue to be monitored for adverse events, blood pressure, liver function, pharmacodynamics, and exploratory biomarkers through Month 12.
Periodic outpatient visits through Month 12
Trial Site Locations
Total: 1 location
1
Clinical Trial Site
Christchurch, New Zealand, 6011
Actively Recruiting
Research Team
C
Corsera Clinical Trial Information Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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