A Study to Evaluate COR-1004 in Adult Volunteers.

NCT07229118 | Recruiting Phase 1 DMC

• 1 other identifier: COR-PCS-25-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done to see if a new, injectable drug called COR-1004 is safe for people to take. It will also help doctors find the right dose of the drug. The study will look at how different dose levels of COR-1004 affect the levels of LDL cholesterol (often called "bad" cholesterol) in the blood. The study will enroll otherwise healthy volunteers who have LDL cholesterol of 100 mg/dl or higher but are not currently taking any cholesterol-lowering medicines. The main purpose of this study is to test a new drug, COR-1004. Researchers want to find out:

• If the drug is safe and if people have any side effects.
• The highest dose that can be given without causing serious side effects.
• How the body processes the drug.
• How the drug affects the amount of "bad" cholesterol in the blood. This is an early-phase study. The information learned will help decide if COR-1004 should be tested in larger studies in the future. To be in this study, you must:
• Be generally healthy.
• Have an LDL ("bad") cholesterol level of 100 mg/dL or higher.
• Not currently be taking any medications to lower your cholesterol. If you decide to join the study, you will be placed into a group by chance, like flipping a coin. This is called "randomization." In each group, most people (8 out of 10) will get a single injection of the study drug (COR-1004). The other people (2 out of 10) will get a placebo. A placebo looks just like the study drug but has no active medicine in it. Using a placebo helps researchers understand the true effects of the real drug. This is a "double-blind" study, which means that neither you nor the study doctor will know if you are getting the study drug or the placebo. The study will test different dose levels of COR-1004. It will start with a low dose and, only if it is proven to be safe, will a new group of participants be given a slightly higher dose. To be extra safe, the first two people in each new dose group will be watched for 24 hours before the other eight people in that group get their injection. After the injection, you will need to visit the study clinic several times over the next year for follow-up. These visits will include:
• Answering questions about your health.
• Physical exams.
• Blood tests to check your safety and your cholesterol levels. A special group of experts, called a Safety Review Committee, will carefully watch over the study to protect all participants. Your active participation in the study, including follow-up visits, will last for about 12 months after you receive the single injection. Because COR-1004 is a new drug, there may be risks that are not yet known. The study staff will explain all the known risks to you before you agree to participate. Known risks may include discomfort at the injection site, like redness, swelling, or pain. The study team will monitor you very closely for any side effects throughout the study.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; lipid-lowering therapy

Outcome Measures

Primary Outcomes (2)

• Occurrence of Clinical and Laboratory Adverse Events within 90 Days post COR-1004 administration

  To evaluate the safety and tolerability of COR-1004 when administered subcutaneously as a single dose to otherwise healthy participants with LDL-C ≥100mg/dL

  Day 1 to Day 90

• Severity of Clinical and Laboratory Adverse Events within 90 Days post COR-1004 administration

  To evaluate the safety and tolerability of COR-1004 when administered subcutaneously as a single dose to otherwise healthy participants with LDL-C ≥100mg/dL

  Day 1 to Day 90

Secondary Outcomes (6)

• To characterize the maximum observed concentration (Cmax)

  Day 1 to Day 90

• To characterize the time of maximum observed concentration (Tmax)

  Day 1 to Day 90

• To characterize the area under the concentration versus time curve (AUC).

  Day 1 to Day 90

• To characterize the elimination half-life (t1/2).

  Day 1 to Day 90

• Absolute change from baseline in LDL-C (direct beta quantification method) and PCSK-9

  Day 1 to Day 90

Study Arms (10)

Cohort 1 - Dose 1 of COR-1004

EXPERIMENTAL

A single dose of COR-1004 will be administered subcutaneously

Drug: COR-1004

Cohort 1 - Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered subcutaneously

Drug: Placebo

Cohort 2 - Dose 2 of COR-1004

EXPERIMENTAL

A single dose of COR-1004 will be administered subcutaneously

Drug: COR-1004

Cohort 2 - Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered subcutaneously

Drug: Placebo

Cohort 3 - Dose 3 of COR-1004

EXPERIMENTAL

A single dose of COR-1004 will be administered subcutaneously

Drug: COR-1004

Cohort 3 - Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered subcutaneously

Drug: Placebo

Cohort 4 - Dose 4 of COR-1004

EXPERIMENTAL

A single dose of COR-1004 will be administered subcutaneously

Drug: COR-1004

Cohort 4 - Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered subcutaneously

Drug: Placebo

Cohort 5 - Dose 5 of COR-1004

EXPERIMENTAL

A single dose of COR-1004 will be administered subcutaneously

Drug: COR-1004

Cohort 5 - Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered subcutaneously

Drug: Placebo

Interventions

COR-1004 DRUG

COR-1004 administered by subcutaneous (SC) injection

Cohort 1 - Dose 1 of COR-1004; Cohort 2 - Dose 2 of COR-1004; Cohort 3 - Dose 3 of COR-1004; Cohort 4 - Dose 4 of COR-1004; Cohort 5 - Dose 5 of COR-1004

Placebo DRUG

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Cohort 1 - Placebo; Cohort 2 - Placebo; Cohort 3 - Placebo; Cohort 4 - Placebo; Cohort 5 - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum LDL-C ≥100 mg/dL (≥2.6 mmol/L) at Screening.
• Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception, one of which should be a barrier method.
• Post-menopausal females must be post-menopausal for 12 months.
• Male participants and their partners of child-bearing potential, or same-sex partners, must be willing to use two highly effective methods of contraception, one of which must be a barrier method (eg, condom) for 90 days after study drug administration.
• Able to participate, and willing to give written informed consent and to comply with the study restrictions.

You may not qualify if:

• Any active or chronic disease.
• Active or history of serious mental illness or psychiatric disorder.
• Clinically significant illness within seven days before study drug administration.
• Having risk of atherosclerotic cardiovascular disease (ASCVD) ≥7.5% based on the ASCVD Risk Estimator Plus.
• Having fasting triglyceride level ≥400 mg/dL (≥4.52 mmol/L).
• Clinically significant abnormalities on physical examination, vital signs, or laboratory test results (except for serum LDL-C) during Screening or prior to admission to the study unit.
• Participants with any risk factors or family history for QT or Fridericia-corrected QT interval (QTcF) prolongation or ECG abnormalities or any abnormality in the ECG.
• Confirmed systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg at Screening, Day -1, or pre-dose.
• Mean resting pulse rate \<40 bpm or \>90 bpm at Screening.
• Abnormal renal function including serum creatinine greater than the upper limit of normal (ULN) or calculated creatinine clearance \<60 mL/min (using the Cockcroft-Gault formula).
• Alanine aminotransferase (ALT) and/or total bilirubin above the ULN. Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma glutamyl transferase (GGT) \>2 × ULN. International normalized ratio (INR) above the upper bound of the normal reference range (as per the local laboratory reference range) at Screening.
• Positive hepatitis B surface antigen, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
• Pregnant or lactating women, or males with female partners who are pregnant or lactating.
• History of multiple drug allergies or history of allergic reaction to an oligonucleotide, N-acetylgalactosamine (GalNAc), or inclisiran.
• Participation in an investigational drug or device study within 45 days or five half-lives (whichever time period is longer) or six months for biologic therapies prior to study drug administration.

Sponsors & Collaborators

• Corsera Health: lead

Study Sites (1)

Clinical Trial Site

Christchurch, 6011, New Zealand

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Corsera Clinical Trial Information Line

CONTACT

781-203-5206; clinicaltrials@corsera.com

Study Design

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

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)