Healthy Volunteers study: CDR132L
Official title A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
ClinicalTrials.gov ID: NCT07656454
What this study is testing
What is CDR132L (i.v.)?
CDR132L (i.v.) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical...
You likely can't join if
- 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]) less than (\<) 90 milliliters per...
See the full eligibility 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...
- 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]) less than (\<) 90 milliliters per minute/1.73square meter (mL/min/1.73m\^2)
- Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 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...
- Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
- Heart rate outside the range of 50-89 beats/minute at screening (visit 1).
- Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart...
- Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin \<90 grams per litre (g/L))
- Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
- Presence of thrombocytopenia, defined as thrombocyte count \<150 x 10\^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.
- Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).
The study team makes the final eligibility decision.
Where it is enrolling
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Berlin, Germany. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.