NCT04921254

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Biosergen AS · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Invasive Fungal Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-23
• Primary completion: 2023-03-01
• Completion: 2023-05-01
• First posted: 2021-06-10
• Last updated: 2022-11-21

Locations

1 site across 1 country: Australia