CLINICAL TRIALS PROFILE FOR APX001

Clinical Trials for APX001

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02956499 ↗	Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously	Completed	Amplyx Pharmaceuticals	Phase 1	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.
NCT02956499 ↗	Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously	Completed	Pfizer	Phase 1	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.
NCT02957929 ↗	Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally	Completed	Amplyx Pharmaceuticals	Phase 1	This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.
NCT02957929 ↗	Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally	Completed	Pfizer	Phase 1	This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.

Clinical Trial Conditions for APX001

Condition Name

Condition Name
Intervention	Trials
Fungal Infection	4
Invasive Fungal Infections	2
Candidemia	2
Invasive Candidiases	1

Condition MeSH

Condition MeSH
Intervention	Trials
Mycoses	6
Candidemia	2
Invasive Fungal Infections	2
Neutropenia	1

Clinical Trial Locations for APX001

Trials by Country

Trials by Country
Location	Trials
United States	11
Germany	3
Netherlands	3
Belgium	2
Spain	2

Trials by US State

Trials by US State
Location	Trials
North Carolina	2
California	2
Utah	1
Massachusetts	1
Texas	1

Clinical Trial Progress for APX001

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	6

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	7
Terminated	1
Recruiting	1

Clinical Trial Sponsors for APX001

Sponsor Name

Sponsor Name
Sponsor	Trials
Amplyx Pharmaceuticals	8
Pfizer	6
The Clinical Trials Centre Cologne	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	14
Other	1