A study to learn how safe the study treatment BAY3401016 is, how it affects the body and how it moves into, through, and out of the body when a single amount is given to healthy male participants

Start 30 May 2023 · End 16 Dec 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol 21891

Overview

Sponsor-declared trial summary

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

Status Ended

Participants planned 126

Countries 1

Sites 2

Alport syndrome

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: 30 May 2023 → 16 Dec 2025
Decision date (initial): 2023-04-21
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Alport syndrome

Version	Level	Code	Term	System organ class
20.0	PT	10001843	Alport's syndrome	100000004850

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 · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	126	2
Rest of world	—	0	—

Investigational sites

Germany

2 sites · Ended

Nuvisan GmbH

Clinical Services, Wegenerstrasse 13, Ludwigsfeld, Neu-Ulm