A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.

PHASE1UnknownINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 23, 2021

Primary Completion Date

March 31, 2023

Study Completion Date

May 31, 2023

Conditions
Invasive Fungal Infections
Interventions
DRUG

BSG005 or placebo

"SAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur.~The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level."

Trial Locations (1)

3004

RECRUITING

Nucleus Network Pty Ltd, Melbourne

Sponsors
All Listed Sponsors
collaborator

Select Pharma Pty Ltd

UNKNOWN

collaborator

Greenlight Clinical

UNKNOWN

collaborator

Nucleus Network Ltd

OTHER

lead

Biosergen AS

INDUSTRY

NCT04921254 - A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005. | Biotech Hunter | Biotech Hunter