Healthy VolunteersPhase 1NCT07656454
A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
A Phase 1 study testing CDR132L (i.v.) and CDR132L (s.c.) in people with Healthy Volunteers and Heart Failure, run by Novo Nordisk A/S at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Heart Failure
- What is being tested?
- CDR132L (i.v.) and CDR132L (s.c.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jun 2026to 31 Dec 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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 significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
- 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 failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Parexel International GmbH
Berlin, 14050
About this study
Official title: A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
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.
- Conditions
- Healthy Volunteers, Heart Failure
- Being tested
- CDR132L (i.v.), CDR132L (s.c.)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR132L (i.v.)Drug
CDR132L will be administered intravenously.
CDR132L (s.c.)Drug
CDR132L will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously. Receives: Drug: CDR132L (i.v.); Drug: CDR132L (s.c.) |
| Sequence B | Experimental | Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously. Receives: Drug: CDR132L (i.v.); Drug: CDR132L (s.c.) |
| Sequence C | Experimental | Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously. Receives: Drug: CDR132L (i.v.); Drug: CDR132L (s.c.) |
| Sequence D | Experimental | Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously. Receives: Drug: CDR132L (i.v.); Drug: CDR132L (s.c.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
Measured as hours*nanograms per milliliter (h*ng/mL)
Measured: From 0 to 840 hours after CDR132L administration
Secondary outcomes (10)
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Measured as h*ng/mL
Measured: From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose
Measured as nanograms per milliliter (ng/mL)
Measured: From 0 to 840 hours after CDR132L administration
Time to maximum observed CDR132L plasma concentration after a single dose
Measured in hours
Measured: From 0 to 840 hours after CDR132L administration
Terminal half-life for CDR132L after a single dose
Measured in hours
Measured: From 0 to 840 hours after CDR132L administration
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, divided by dose
Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg)
Measured: From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose divided by dose
Measured as nanograms per milliliter per milligram (ng/mL/mg)
Measured: From 0 to 840 hours after CDR132L administration
Total plasma clearance of CDR132L after a single dose
Measured as liters per hour
Measured: From 0 to 840 hours after CDR132L administration
Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values
Measured in liters
Measured: From 0 to 840 hours after CDR132L administration
Mean residence time for CDR132L after a single dose
Measured in hours
Measured: From 0 to 840 hours after CDR132L administration
Number of adverse events
Measured as number of events
Measured: From first CDR132L administration (day 1) to day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start17 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656454
- Sponsor's protocol ID
- NN6706-8230
- Other IDs
- U1111-1319-6249, 2025-521329-34, 2025
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT07656454
- Acronym / sponsor ID
- NN6706-8230
- Conditions
- Healthy Volunteers, Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: CDR132L (i.v.), Drug: CDR132L (s.c.)Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously. |
| Sequence B | Experimental | Drug: CDR132L (i.v.), Drug: CDR132L (s.c.)Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously. |
| Sequence C | Experimental | Drug: CDR132L (i.v.), Drug: CDR132L (s.c.)Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously. |
| Sequence D | Experimental | Drug: CDR132L (i.v.), Drug: CDR132L (s.c.)Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
- 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 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 failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
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 |
|---|---|---|
| CDR132L (i.v.)CDR132L will be administered intravenously. | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
| CDR132L (s.c.)CDR132L will be administered subcutaneously. | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
Primary outcome
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
Time frame: From 0 to 840 hours after CDR132L administration
Measured as hours*nanograms per milliliter (h*ng/mL)
10 secondary outcomes
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
Time to maximum observed CDR132L plasma concentration after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
Terminal half-life for CDR132L after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
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, divided by dose
Time frame: From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose divided by dose
Time frame: From 0 to 840 hours after CDR132L administration
Total plasma clearance of CDR132L after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values
Time frame: From 0 to 840 hours after CDR132L administration
Mean residence time for CDR132L after a single dose
Time frame: From 0 to 840 hours after CDR132L administration
Number of adverse events
Time frame: From first CDR132L administration (day 1) to day 141
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Screening Protocol
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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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDR132L (i.v.) and CDR132L (s.c.) in people with Healthy Volunteers and Heart Failure, run by Novo Nordisk A/S at 1 site in Germany.
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 4 inclusion and 15 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration (time frame: From 0 to 840 hours after CDR132L administration). 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 30 Jun 2026.