Clinical trial • Phase I • Respiratory

BV100 for Healthy volunteers | Acinetobacter baumannii infection

Phase I trial of BV100 for Healthy volunteers | Acinetobacter baumannii infection. None/Not specified-controlled. 16 participants.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Healthy volunteers | Acinetobacter baumannii infection
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
28-10-2025
First CTIS Authorization Date
01-03-2026

Trial design

None/Not specified-controlled Phase I trial across 1 site in Austria.

Comparator
None/Not specified
Target Sample Size
16

Eligibility

Recruits 16 No vulnerable population selected; participants are Healthy volunteers..

Vulnerable Population
No vulnerable population selected; participants are Healthy volunteers.

Recruitment

Planned Sample Size
16
Recruitment Window Months
13

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Austria

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
01-03-2026
Processing Time Days
26
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Clinical Pharmacology
Principal Investigator Name
Markus Zeitlinger
Principal Investigator Email
markus.zeitlinger@meduniwien.ac.at
Contact Person Name
Markus Zeitlinger

Sponsor

Primary sponsor

Full Name
Bioversys S.A.S.
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
BV100
Active Substance
BV100
Investigational Product Name
Polymyxin B
Active Substance
Polymyxin B
Modality
Peptide/protein/enzyme
Combination Treatment
Yes

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