Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT07229118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate COR-1004 in Adult Volunteers.
Sponsor:
Corsera Health
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, single-ascending-dose study of COR 1004 administered SC to participants with LDL-C ≥100 mg/dL who are otherwise healthy and not on lipid-lowering therapy.
Each cohort will be comprised of 10 participants randomized 4:1 to receive a single dose of study drug or placebo, respectively.
Monitoring will continue on an outpatient basis, with participants returning to the clinical study site for safety, tolerability, PK, PD, and exploratory biomarker monitoring at specified time points through Day 90. Following Day 90, participants will continue to be monitored for adverse events, blood pressure, liver function tests, PD, and exploratory biomarkers through Month 12.
Dosing in Cohorts 1 to 5 will use a sentinel dosing approach, with the first two participants (one active and one placebo) receiving COR-1004 or placebo 24 hours prior to the remainder of the cohort. If deemed safe and tolerated after 24 hours, and no dose-limiting toxicity is observed by the investigator, the remainder of the cohort will be dosed as planned. The sentinel dosing approach will not be utilized for Cohort 6.
Each cohort will be comprised of 10 participants randomized 4:1 to receive a single dose of study drug or placebo, respectively.
Monitoring will continue on an outpatient basis, with participants returning to the clinical study site for safety, tolerability, PK, PD, and exploratory biomarker monitoring at specified time points through Day 90. Following Day 90, participants will continue to be monitored for adverse events, blood pressure, liver function tests, PD, and exploratory biomarkers through Month 12.
Dosing in Cohorts 1 to 5 will use a sentinel dosing approach, with the first two participants (one active and one placebo) receiving COR-1004 or placebo 24 hours prior to the remainder of the cohort. If deemed safe and tolerated after 24 hours, and no dose-limiting toxicity is observed by the investigator, the remainder of the cohort will be dosed as planned. The sentinel dosing approach will not be utilized for Cohort 6.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: