Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
Recruiting
Phase 1
Phase 2
Interventional Study
Invasive Fungal Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Biosergen AS · Industry
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About This Trial
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 patie…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18 years.
2. Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
3. Diagnosed by Investigator to have an IFI.
\- Proven IFIs as defined in the 2020 consensus definitions by t…
Contacts