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Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection

NCT06678113 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-06

No results posted yet for this study

Summary

This study is an open-label, Phase 1b, dose-escalation/finding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI).

Approximately 15 patients are planned to be enrolled in 3 cohorts. The study will be conducted in 3 cohorts consisting of 3 periods, namely: Screening, Treatment, and Follow-up periods. In each cohort, 5 patients are planned to be enrolled.

This study is a single-arm study. The treatment (BSG005) in each dose level will be administered once daily for 3 days via IV infusion. If the safety and tolerability profiles are acceptable at each dose level, the patients will be treated for a maximum of 28 days. Each patient will be in the study for up to 50 days, which consists of a 7-day Screening period, 1 day for baseline assessments, up to 28 days (maximum) of treatment with BSG005, and 14 days of follow-up.

Conditions

  • Invasive Fungal Infection

Interventions

DRUG

BSG005

Single arm dose escalation in patients with invasive fungal infection

Sponsors & Collaborators

  • Alkem Laboratories Ltd

    collaborator INDUSTRY

  • JSS Medical Research Asia pacific Private Limited

    collaborator UNKNOWN

  • Biosergen AS

    lead INDUSTRY

Principal Investigators

  • Tine Olesen, PhD · BIOSERGEN AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-01
Completion
2026-04-01

Countries

  • India

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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 NCT06678113 on ClinicalTrials.gov