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).

Start 14 Sep 2023 · End 20 May 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 20799

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ended

Participants planned 91

Countries 1

Sites 1

Pulmonary hypertension due to left heart disease

Key facts

Sponsor: Bayer AG
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 14 Sep 2023 → 20 May 2025
Decision date (initial): 2023-07-21
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-503368-18-00
ClinicalTrials.gov: NCT06048120

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Pulmonary hypertension due to left heart disease

Version	Level	Code	Term	System organ class
20.0	LLT	10020787	Hypertension pulmonary	10038738

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation: Bayer AG
City: Leverkusen
Postcode: 51368
Country: Germany

Scientific contact point

Organisation: Bayer AG
Contact name: Therapeutic Area Head

Public contact point

Organisation: Bayer AG
Contact name: Therapeutic Area Head

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	91	1
Rest of world	—	0	—

Investigational sites

Germany

1 site · Ended

Nuvisan GmbH

Clinical Services, Wegenerstrasse 13, Ludwigsfeld, Neu-Ulm

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2023-09-14	2025-05-20	2023-09-15	2025-03-14

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-04-28	Germany	Acceptable 2023-07-20	2023-07-21
2	SUBSTANTIAL MODIFICATION	SM-1	2023-07-27	Germany	Acceptable	2023-08-02
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-02-19	Germany	Acceptable	2024-02-19
4	SUBSTANTIAL MODIFICATION	SM-2	2024-05-23	Germany	Acceptable 2024-07-18	2024-07-19
5	NON SUBSTANTIAL MODIFICATION	NSM-2	2024-09-18	Germany	Acceptable 2024-07-18	2024-09-18
6	SUBSTANTIAL MODIFICATION	SM-3	2024-11-27	Germany	Acceptable 2024-12-13	2024-12-13