NCT05491733 is a Phase 1 clinical trial of APX001 in Invasive Fungal Infections, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT05491733?

NCT05491733 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT05491733?

Interventions in NCT05491733: APX001, APX001A.

What condition does NCT05491733 study?

NCT05491733 studies Invasive Fungal Infections.

Is NCT05491733 still recruiting?

NCT05491733 is currently completed. Last updated 11 July 2024.

Last reviewed 2024-07-11 · How we verify

NCT05491733

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Bioequivalence Study of APX001 High-load and Low-load Tablets

Completed Phase 1 Last updated 11 July 2024

What this trial tests

Phase 1 trial testing APX001 in Invasive Fungal Infections in 18 participants. Completed in 23 June 2021.

Timeline

2 March 2021

Primary endpoint
13 May 2021

23 June 2021

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	18
Start date	2 March 2021
Primary completion	13 May 2021
Estimated completion	23 June 2021
Sites	1 location across United States

Drugs / interventions tested

APX001 — full drug profile →
APX001A — full drug profile →

Conditions studied

Invasive Fungal Infections — all drugs for Invasive Fungal Infections →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 18 to 65, any sex, with Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fosmanogepix: The Novel Anti-Fungal Agent's Comprehensive Review of in Vitro, in Vivo, and Current Insights From Advancing Clinical Trials.
Almajid A, Bazroon A, Al-Awami HM, Albarbari H, et al · · 2024 · cited 14× · PMID 38807795 · DOI 10.7759/cureus.59210

Verify or expand the search:

Other trials of APX001

Trials testing the same drug.

NCT04148287 — An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris · Phase 2 · completed
NCT04166669 — A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 · Phase 1 · completed
NCT03604705 — An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia · Phase 2 · completed

Other recruiting trials for Invasive Fungal Infections

Currently open trials in the same condition.

NCT06537726 — Breath Analysis for the Detection of Invasive Fungal Infections · recruiting
NCT05688592 — Usefulness of PET-CT for Invasive Fungal Infection · recruiting
NCT05750706 — Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative · recruiting
NCT06103331 — Fungal Surveillance in Bangladesh · recruiting

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05491733 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 11 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05491733.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing