NCT02956499

Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a total of approximately 48 healthy subjects. The MAD portion of the study will enroll four cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy subjects.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	APX001 single dose 1
DRUG	APX001 single dose 2
DRUG	APX001 single dose 3
DRUG	APX001 single dose 4
DRUG	APX001 single dose 5
DRUG	APX001 single dose 6
DRUG	APX001 multiple dose 1
DRUG	APX001 multiple dose 2
DRUG	APX001 multiple dose 3
DRUG	APX001 multiple dose 4
DRUG	Matching Placebo

Timeline

• Start date: 2016-05-24
• Primary completion: 2017-07-03
• Completion: 2017-07-03
• First posted: 2016-11-07
• Last updated: 2025-09-10

Locations

2 sites across 1 country: Netherlands