A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Comp… (NCT07656454) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
Germany32 participantsStarted 2026-06-17
Plain-language summary
This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female (sex at birth).
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index 18.5-29.9 kilograms per square metre (kg/m\^2) (both inclusive) and body weight less than or equal to (≤120) kilograms (kg) at screening (visit 1).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.
Exclusion Criteria:
* Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
* Alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) +10 percentage (%)
* Aspartate aminotransferase (AST) \>ULN +20%
* Bilirubin \>ULN +20%
* Creatinine \>ULN +10%
* Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \<90 milliliters per minute (mL/min) /1.73 square meter (m\^2)
* Urine albumin-to-creatinine ratio (UACR) ≥30 milligrams per gram (mg/g)
* Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
* Supine blood pres…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two injection methods — under the skin versus into a vein — for a drug called CDR132L, and it's only enrolling healthy volunteers right now, so does that mean there's no option yet for someone already living with heart failure to participate?
2Since this is a Phase 1 study focused on how much CDR132L gets absorbed into the bloodstream rather than whether it actually treats heart failure, what does that tell us about how early this drug is in development and how much safety and effectiveness data currently exists?
3The trial hasn't started recruiting yet — given where I am in my heart failure diagnosis, would it make more sense to focus on established treatments or other trials that are further along while we wait to see if this one opens?
4CDR132L is being tested in healthy volunteers to understand basic absorption — what is this drug designed to do for heart failure, and is there any earlier research you're aware of that might tell us whether it's shown any promise so far?
5If this trial does eventually open to heart failure patients in later phases, what would I need to know about my current condition or treatment history to even have a conversation about whether something like this could be worth considering down the road?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under Curve (AUC) 0-tz,CDR132L,SD; area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
Timeframe: From 0 to 840 hours after CDR132L administration