Fungal Infection
Conditions
Brief 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.
Interventions
DRUGAPX001 single dose 1
DRUGAPX001 single dose 2
DRUGAPX001 single dose 3
DRUGAPX001 single dose 4
DRUGAPX001 single dose 5
DRUGAPX001 single dose 6
DRUGAPX001 multiple dose 1
DRUGAPX001 multiple dose 2
DRUGAPX001 multiple dose 3
DRUGAPX001 multiple dose 4
DRUGMatching Placebo
Sponsors
Basilea Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax). | 21 days |
| Pharmacokinetics of single and multiple doses of APX001 as measured by area under the curve (AUC). | 21 days |
| Pharmacokinetics of single and multiple dose of APX001 as measured by accumulation ratio. | 21 days |
| Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd). | 21 days |
| Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel). | 21 days |
| Pharmacokinetics of single and multiple doses of APX001 as measured by terminal phase half-life (t1/2). | 21 days |
Countries
Netherlands
Outcome results
None listed