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BAY2701250

Phase 1

Pulmonary Hypertension Due to Left Heart Disease | Small molecule | Cardiovascular |Bayer AG|Trials Updated: May 28, 2025

BAY2701250 target and mechanism

ModalitySmall molecule

Also known as BAY2701250 IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

BAY2701250 clinical trials

BAY2701250 · 1 trial · 1 indication

Phase 1 1
NCT06048120A 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)Pulmonary Hypertension Due to Left Heart Disease
COMPLETED82 Analytics
PHASE1COMPLETED
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)
Pulmonary Hypertension Due to Left Heart DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events (TEAEs)
From administration of study intervention until last follow-up visit, up to 46 (+3) days after administration

Secondary Endpoints

AUC of BAY2701250 in plasma
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
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
From pre-dose up to 77 days after i.v. administration, respectively up to 81 days after s.c. administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
i.v. infusion cohortsEXPERIMENTALEach 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 cohortsEXPERIMENTALEach 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.

Interventions

NameTypeDescription
BAY2701250 IVDRUGSingle does, intravenous infusion
Placebo IVDRUGMatching placebo for BAY2701250 IV
BAY2701250 SCDRUGSingle dose, subcutaneous injection will be administered into abdominal subcutaneous fat tissue
Placebo SCDRUGMatching placebo for BAY2701250 SC
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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) wi...

Countries:Germany
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Frequently asked questions about BAY2701250

What is BAY2701250?

BAY2701250 is an investigational small molecule being developed by Bayer AG for pulmonary hypertension due to left heart disease, a cardiovascular condition. It is in Phase 1 clinical development and has been studied in healthy male volunteers. It is not an approved therapy.

What is BAY2701250 used for?

BAY2701250 is being studied for pulmonary hypertension due to left heart disease. The only completed trial enrolled healthy male participants rather than patients with the condition, so the program remains at an early research stage and no approved use exists for BAY2701250.

Who is developing BAY2701250?

BAY2701250 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 study of the compound conducted in Germany.

What phase is BAY2701250 in?

BAY2701250 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA or any other regulator for any indication.

What clinical trials is BAY2701250 in?

BAY2701250 has been evaluated in one completed Phase 1 trial, NCT06048120. That study enrolled 82 healthy male participants aged 18 and older in Germany and compared single intravenous infusion and subcutaneous injection doses in a controlled, randomized design. No trials are currently active.

Is BAY2701250 the same as BAY2701250 IV?

Yes. BAY2701250 IV is an alternative name for BAY2701250, reflecting the intravenous infusion route tested in its Phase 1 study. The same compound was also given as a subcutaneous injection in that trial, which enrolled 82 healthy male volunteers.