HyperlipidemiaPhase 1NCT07229118
A Study to Evaluate COR-1004 in Adult Volunteers.
A Phase 1 study testing COR-1004 in people with Hyperlipidemia, run by Corsera Health at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- COR-1004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 28 Nov 2025to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 must be willing to use two highly effective methods of contraception, one of which must be a barrier method (e.g., condom) through the end of the study (Day 360). Male participants and their same-sex partners must use a barrier method of contraception. Male participants must be willing not to donate sperm until the end of the study. Male participants who had vasectomy must provide the date of the procedure.
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
Who cannot join
- 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.
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- 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 estimated glomerular filtration rate (eGFR) <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.
- Received small interfering ribonucleic acid (siRNA) as an investigational or approved product prior to study drug administration.
- Use of any medications (prescription or over-the-counter) or herbal supplements within two weeks or five half-lives (whichever is longer) prior to study drug administration (six months for biologic therapies), with exception of acetaminophen/paracetamol up to 2 g per day up to 48 hours prior to dosing or medications for contraception. Other exceptions will only be made if the rationale is discussed and clearly documented between the Clinical Research Organization and Sponsor.
- Received any medication, herbal supplements, or nutraceutical known to alter serum lipids within 30 days before Screening (eg, niacin).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand2 sites, 2 recruiting
- Recruiting
Clinical Trial Site 1
Christchurch, 8011
- Recruiting
Clinical Trial Site 2
Wellington, 6011
About this study
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
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:
Read more
- 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 the next 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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- COR-1004, Placebo
- Keywords
- Hyperlipidemia, lipid-lowering therapy
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR-1004Drug
COR-1004 administered by subcutaneous (SC) injection
PlaceboDrug
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Dose 1 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 1 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 2 - Dose 2 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 2 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 3 - Dose 3 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 3 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 4 - Dose 4 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 4 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 5 - Dose 5 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 5 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 7 - Dose 6 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 7 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 8 - Dose 7 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 8 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
| Cohort 9 - Dose 8 of COR-1004 | Experimental | A single dose of COR-1004 will be administered subcutaneously Receives: Drug: COR-1004 |
| Cohort 9 - Placebo | Placebo comparator | A single dose of placebo will be administered subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1 to Day 90
Secondary outcomes (6)
To characterize the maximum observed concentration (Cmax)
Measured: Day 1 to Day 90
To characterize the time of maximum observed concentration (Tmax)
Measured: Day 1 to Day 90
To characterize the area under the concentration versus time curve (AUC).
Measured: Day 1 to Day 90
To characterize the elimination half-life (t1/2).
Measured: Day 1 to Day 90
Absolute change from baseline in LDL-C (direct beta quantification method) and PCSK-9
Measured: Day 1 to Day 90
Percent change from baseline in LDL-C (direct beta quantification method) and PCSK-9
Measured: Day 1 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start28 Nov 2025
- Primary completionFeb 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsera Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229118
- Sponsor's protocol ID
- COR-PCS-25-101
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07229118
- Acronym / sponsor ID
- COR-PCS-25-101
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, lipid-lowering therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Corsera HealthIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the next 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Dose 1 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 1 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 2 - Dose 2 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 2 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 3 - Dose 3 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 3 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 4 - Dose 4 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 4 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 5 - Dose 5 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 5 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 7 - Dose 6 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 7 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 8 - Dose 7 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 8 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
| Cohort 9 - Dose 8 of COR-1004 | Experimental | Drug: COR-1004A single dose of COR-1004 will be administered subcutaneously |
| Cohort 9 - Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 must be willing to use two highly effective methods of contraception, one of which must be a barrier method (e.g., condom) through the end of the study (Day 360). Male participants and their same-sex partners must use a barrier method of contraception. Male participants must be willing not to donate sperm until the end of the study. Male participants who had vasectomy must provide the date of the procedure.
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COR-1004COR-1004 administered by subcutaneous (SC) injection | Drug | 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, Cohort 7 - Dose 6 of COR-1004, Cohort 8 - Dose 7 of COR-1004, Cohort 9 - Dose 8 of COR-1004 |
| PlaceboSterile 0.9% (w/v) saline will be used as placebo treatment during the study. | Drug | Cohort 1 - Placebo, Cohort 2 - Placebo, Cohort 3 - Placebo, Cohort 4 - Placebo, Cohort 5 - Placebo, Cohort 7 - Placebo, Cohort 8 - Placebo, Cohort 9 - Placebo |
Primary outcome
Occurrence of Clinical and Laboratory Adverse Events within 90 Days post COR-1004 administration
Time frame: Day 1 to Day 90
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
Severity of Clinical and Laboratory Adverse Events within 90 Days post COR-1004 administration
Time frame: Day 1 to Day 90
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
6 secondary outcomes
To characterize the maximum observed concentration (Cmax)
Time frame: Day 1 to Day 90
To characterize the time of maximum observed concentration (Tmax)
Time frame: Day 1 to Day 90
To characterize the area under the concentration versus time curve (AUC).
Time frame: Day 1 to Day 90
To characterize the elimination half-life (t1/2).
Time frame: Day 1 to Day 90
Absolute change from baseline in LDL-C (direct beta quantification method) and PCSK-9
Time frame: Day 1 to Day 90
Percent change from baseline in LDL-C (direct beta quantification method) and PCSK-9
Time frame: Day 1 to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COR-1004 in people with Hyperlipidemia, run by Corsera Health at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corsera Clinical Trial Information Line (781-203-5206, clinicaltrials@corsera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Clinical and Laboratory Adverse Events within 90 Days post COR-1004 administration (time frame: Day 1 to Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.