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

NCT04921254 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-11-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Select Pharma Pty Ltd

    collaborator UNKNOWN

  • Greenlight Clinical

    collaborator UNKNOWN

  • Nucleus Network Ltd

    collaborator OTHER

  • Biosergen AS

    lead INDUSTRY

Principal Investigators

  • Philippe Ryan, MD · Nucleus Network, Melbourne site, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2023-03-31
Completion
2023-05-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921254 on ClinicalTrials.gov