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BAY2701250

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

BAY2701250 is an investigational small molecule being developed for pulmonary hypertension due to left heart disease. It is a cardiovascular therapy currently in Phase 1 clinical development. The drug is not approved and remains under study to evaluate its safety, effects on the body, and how it moves through the body.

Who makes BAY2701250?

BAY2701250 is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The company is conducting clinical research on this investigational small molecule for the treatment of pulmonary hypertension due to left heart disease.

What phase is BAY2701250 in?

BAY2701250 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for pulmonary hypertension due to left heart disease.

What clinical trials is BAY2701250 in?

BAY2701250 has one completed Phase 1 clinical trial, identified as NCT06048120. This study enrolled 82 healthy male participants in Germany and evaluated the safety, tolerability, and pharmacokinetics of a single dose administered as an intravenous infusion or subcutaneous injection.

How does BAY2701250 work?

The mechanism of action for BAY2701250 has not been disclosed in available information. It is classified as a small molecule therapeutic being investigated for pulmonary hypertension due to left heart disease, but its specific molecular target is not publicly detailed.