Pulmonary Hypertension Due to Left Heart DiseasePhase 1NCT06048120
A Study to Learn How Safe the Study Treatment BAY2701250 is, How it Affects the Body and How it Moves Into, Through and Out of the Body in Healthy Male Participants When a Single Amount is Given as an Injection Into the Vein (Intravenous Infusion) or Under the Skin (Subcutaneous Injection)
A Phase 1 study testing BAY2701250 IV and BAY2701250 SC in people with Pulmonary Hypertension Due to Left Heart Disease, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by diseases in the left side of the heart. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension Due to Left Heart Disease
- What is being tested?
- BAY2701250 IV and BAY2701250 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2023to 20 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, white participants aged 18 to 45 years
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
- Body weight ≥ 70 kg and ≤ 100 kg as well as body mass index (BMI) within the range of 18.0 to 29.9 kg/m^2 (inclusive)
- The informed consent must be signed before any study specific tests or procedures are done
- Ability to understand and follow study-related instructions
Who cannot join
- Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator
- Thyroid disorders as evidenced by assessment of thyroid-stimulating hormone levels outside the normal reference range and confirmed by triiodothyronine and thyroxine at screening
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations)
- Relevant diseases within the last 4 weeks prior to the administration of study intervention
- Febrile illness within 1 week before the administration of study intervention
- Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope
Show all 23Show fewer
- Regular use of medicines
- Use of any drug within 14 days before the administration of study intervention, except single doses of paracetamol, ibuprofen or topical medicines
- Previous (within 90 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s)
- Clinically relevant findings in the physical examination
- Clinically relevant findings in the electrocardiogram (ECG)
- Systolic BP below 100 or above 140 mmHg at screening for all cohorts except for the additional optional Dose Step 8 (Cohort 8) for which systolic BP below 110 or above 140 mmHg at screening will be applicable
- Diastolic blood pressure (BP) below 60 or above 90 mmHg at screening
- Pulse rate below 50 or above 90 beats per minute at screening
- Positive urine drug screening
- Positive alcohol breath test
- Positive results for human immunodeficiency virus (HIV) antibodies (anti-HIV 1+2), or HIVp24 antigen
- Positive results for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV)
- Clinically relevant deviations of the screened safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges at screening
- Smoking
- Regular daily consumption of more than 1 L of methylxanthine-containing beverages
- Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
- Unable/unwilling to comply with study restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-man Single-dose Escalation Study in a Randomized, Single-blind, Placebo-controlled, Group-comparison Design to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 2701250 After Single Short-time Intravenous Infusion or Subcutaneous Administration in Healthy Male Participants.
Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by diseases in the left side of the heart.
The study treatment, BAY2701250 is under development and will be tested in humans for the first time in this study. Once it is approved, it may help treat people with PH due to left heart disease.
Read more
The participants of this study will be healthy and will have no benefit from the administration of BAY2701250. However, the study will provide important information for the design of subsequent studies with BAY2701250 in people with PH due to left heart disease. The participants will be randomly (by chance) assigned to receive either placebo or BAY2701250 as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection). A placebo is a treatment that looks like a medicine but does not have any medicine in it.
The main purpose of this first in human study is to learn how safe is BAY2701250 and to what degree medical problems caused by it can be tolerated by the study participants after they receive a single amount (dose) either as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection)?
To answer this, the researchers will collect the number of study participants with medical problems (also called adverse events) after receiving BAY2701250 until the end of the study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatment.
Further objectives of this study are to learn how does a single dose of BAY2701250 move into, through and out the body of the participants after an intravenous infusion or a subcutaneous injection?
To answer this, the researchers will measure:
- The (average) total level of BAY2701250 in the blood (also called AUC)
- AUC divided by dose (also called AUC/D)
- The (average) highest level of BAY2701250 in the blood (also called Cmax)
- Cmax divided by dose (Cmax/D) after receiving either an intravenous infusion or subcutaneous injection of BAY2701250.
A group of participants will start out by receiving a low dose of BAY2701250. The study doctors will look at the results from these participants and then decide whether to increase the dose of BAY2701250 in the next group of participants.
Each participant will be in the study for approximately 9-10 weeks, including a first test (screening) phase, an in-house stay of a maximum of 14 days and a follow-up phase after the end of treatment.
One visit to the study site is planned during the screening phase, followed by 6 visits (two of which are optional) after the end of treatment.
During the study, the study team will, among other:
- take blood and urine samples
- do physical examinations
- examine heart health using electrocardiogram (ECG) and
- check vital signs such as blood pressure, heart rate and body temperature
- Being tested
- BAY2701250 IV, Placebo IV, BAY2701250 SC, Placebo SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2701250 IVDrug
Single does, intravenous infusion
Placebo IVDrug
Matching placebo for BAY2701250 IV
BAY2701250 SCDrug
Single dose, subcutaneous injection will be administered into abdominal subcutaneous fat tissue
Placebo SCDrug
Matching placebo for BAY2701250 SC
| Study group | Role | What they receive |
|---|---|---|
| i.v. infusion cohorts | Experimental | Each participant will receive a single dose of study intervention, either BAY2701250 or placebo. Study intervention will be administered by means of short time i.v. infusion. Up to 8 dose steps are planned to be investigated for i.v. administration. Receives: Drug: BAY2701250 IV; Drug: Placebo IV |
| s.c. injection cohorts | Experimental | Each participant will receive a single dose of study intervention, either BAY2701250 or placebo. Study intervention will be administered by means of s.c. injection. Up to 2 dose steps are planned to be investigated for s.c. administration. Receives: Drug: BAY2701250 SC; Drug: Placebo SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From administration of study intervention until last follow-up visit, up to 46 (+3) days after administration
Secondary outcomes (5)
AUC of BAY2701250 in plasma
AUC: Area under the concentration vs. time curve from zero to infinity after single dose
AUC(0-t), may be evaluated as main parameter if AUC cannot be reliably determined in all participants
Measured: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
AUC/D of BAY2701250 in plasma
AUC(0-t)/D, may be evaluated as main parameter if AUC/D cannot be reliably determined in all participants
Measured: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
Cmax of BAY2701250 in plasma
Cmax: Maximum observed drug concentration
Measured: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
Cmax/D of BAY2701250 in plasma
Measured: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
F as ratio of the respective s.c. to i.v. values determined for AUC
F: Absolute bioavailability
Measured: From pre-dose up to 81 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to Left Heart DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study will be conducted in a single-center, single-blind, randomized, placebo-controlled, group-comparison, dose escalation design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048120
- Sponsor's protocol ID
- 20799
- Other IDs
- 2023-503368-18-00, 2023
- Status last verified
- May 2025
- First submitted
- 5 Sep 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Single-dose Escalation Study in a Randomized, Single-blind, Placebo-controlled, Group-comparison Design to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 2701250 After Single Short-time Intravenous Infusion or Subcutaneous Administration in Healthy Male Participants.
- ClinicalTrials.gov ID
- NCT06048120
- Acronym / sponsor ID
- 20799
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 21 Sep 2023 (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.
Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by diseases in the left side of the heart.
The study treatment, BAY2701250 is under development and will be tested in humans for the first time in this study. Once it is approved, it may help treat people with PH due to left heart disease.
The participants of this study will be healthy and will have no benefit from the administration of BAY2701250. However, the study will provide important information for the design of subsequent studies with BAY2701250 in people with PH due to left heart disease. The participants will be randomly (by chance) assigned to receive either placebo or BAY2701250 as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection). A placebo is a treatment that looks like a medicine but does not have any medicine in it.
The main purpose of this first in human study is to learn how safe is BAY2701250 and to what degree medical problems caused by it can be tolerated by the study participants after they receive a single amount (dose) either as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection)?
To answer this, the researchers will collect the number of study participants with medical problems (also called adverse events) after receiving BAY2701250 until the end of the study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatment.
Further objectives of this study are to learn how does a single dose of BAY2701250 move into, through and out the body of the participants after an intravenous infusion or a subcutaneous injection?
To answer this, the researchers will measure:
- The (average) total level of BAY2701250 in the blood (also called AUC)
- AUC divided by dose (also called AUC/D)
- The (average) highest level of BAY2701250 in the blood (also called Cmax)
- Cmax divided by dose (Cmax/D) after receiving either an intravenous infusion or subcutaneous injection of BAY2701250.
A group of participants will start out by receiving a low dose of BAY2701250. The study doctors will look at the results from these participants and then decide whether to increase the dose of BAY2701250 in the next group of participants.
Each participant will be in the study for approximately 9-10 weeks, including a first test (screening) phase, an in-house stay of a maximum of 14 days and a follow-up phase after the end of treatment.
One visit to the study site is planned during the screening phase, followed by 6 visits (two of which are optional) after the end of treatment.
During the study, the study team will, among other:
- take blood and urine samples
- do physical examinations
- examine heart health using electrocardiogram (ECG) and
- check vital signs such as blood pressure, heart rate and body temperature
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be conducted in a single-center, single-blind, randomized, placebo-controlled, group-comparison, dose escalation design
| Arm | Type | Receives |
|---|---|---|
| i.v. infusion cohorts | Experimental | Drug: BAY2701250 IV, Drug: Placebo IVEach participant will receive a single dose of study intervention, either BAY2701250 or placebo. Study intervention will be administered by means of short time i.v. infusion. Up to 8 dose steps are planned to be investigated for i.v. administration. |
| s.c. injection cohorts | Experimental | Drug: BAY2701250 SC, Drug: Placebo SCEach participant will receive a single dose of study intervention, either BAY2701250 or placebo. Study intervention will be administered by means of s.c. injection. Up to 2 dose steps are planned to be investigated for s.c. administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male, white participants aged 18 to 45 years
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
- Body weight ≥ 70 kg and ≤ 100 kg as well as body mass index (BMI) within the range of 18.0 to 29.9 kg/m^2 (inclusive)
- The informed consent must be signed before any study specific tests or procedures are done
- Ability to understand and follow study-related instructions
Key exclusion criteria (23 listed)
- Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator
- Thyroid disorders as evidenced by assessment of thyroid-stimulating hormone levels outside the normal reference range and confirmed by triiodothyronine and thyroxine at screening
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations)
- Relevant diseases within the last 4 weeks prior to the administration of study intervention
- Febrile illness within 1 week before the administration of study intervention
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 |
|---|---|---|
| BAY2701250 IVSingle does, intravenous infusion | Drug | i.v. infusion cohorts |
| Placebo IVMatching placebo for BAY2701250 IV | Drug | i.v. infusion cohorts |
| BAY2701250 SCSingle dose, subcutaneous injection will be administered into abdominal subcutaneous fat tissue | Drug | s.c. injection cohorts |
| Placebo SCMatching placebo for BAY2701250 SC | Drug | s.c. injection cohorts |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From administration of study intervention until last follow-up visit, up to 46 (+3) days after administration
5 secondary outcomes
AUC of BAY2701250 in plasma
Time frame: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
AUC/D of BAY2701250 in plasma
Time frame: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
Cmax of BAY2701250 in plasma
Time frame: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
Cmax/D of BAY2701250 in plasma
Time frame: From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
F as ratio of the respective s.c. to i.v. values determined for AUC
Time frame: From pre-dose up to 81 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 BAY2701250 IV and BAY2701250 SC in people with Pulmonary Hypertension Due to Left Heart Disease, run by Bayer 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 28 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: From administration of study intervention until last follow-up visit, up to 46 (+3) days after 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 28 May 2025.