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

Invasive Fungal Infections Clinical Trial

Official title:
A Phase 1, Double-blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of BSG005 Following Single and Multiple Ascending Doses in Healthy Subjects

Clinical Trial Summary

A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part

Clinical Trial Description

The study will investigate the safety and tolerability of BSG005 in healthy subjects. The study will also include pharmacokinetic investigations. There will be an ascending single dose part (SAD) with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug. This concept will be replicated in the multiple ascending dose (MAD) part. There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee (SRC) has approved the escalation to next dose level. The key parameters are infusion reactions, kidney, liver and potassium changes during and after administration of BSG005. Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days. Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days. Pharmacokinetics at day 1 and day 7 will be investigated. Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04921254
Study type Interventional
Source Biosergen AS
Contact Peder M Andersen, MD
Phone +45 20802470
Email peder.andersen@biosergen.net
Status Recruiting
Phase Phase 1
Start date August 23, 2021
Completion date May 2023
View Details
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