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

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956499
• Other study ID #: APX001-101
• Secondary ID: C4791001
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2016
• Est. completion date: July 3, 2017

Study information

• Verified date: May 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug.

• Males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug.

• Screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health.

• No significantly abnormal findings on physical examination, ECG and vital signs.

• Willing and able to provide written informed consent.

Exclusion Criteria:

• Any uncontrolled or active major systemic disease including, but not limited to:

cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.

• History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.

• Use of prescription medication within 14 days prior to the first dose of study drug and throughout the study.

• Use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study.

• Positive results on any of the following Screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• APX001 single dose 1

• APX001 single dose 2

• APX001 single dose 3

• APX001 single dose 4

• APX001 single dose 5

• APX001 single dose 6

• APX001 multiple dose 1

• APX001 multiple dose 2

• APX001 multiple dose 3

• APX001 multiple dose 4

• Matching Placebo

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single and multiple doses of APX001 as measured by adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by area under the curve (AUC).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by terminal phase half-life (t1/2).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).		21 days
Secondary	Pharmacokinetics of single and multiple dose of APX001 as measured by accumulation ratio.		21 days