Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously

• ClinicalTrials.gov Identifier: NCT02956499
• Recruitment Status: Completed
• First Posted: November 6, 2016
• Last Update Posted: August 2, 2017
• Sponsor: Amplyx Pharmaceuticals
• Information provided by (Responsible Party): Amplyx Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fungal Infection	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	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: July 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1; single intravenous dose	Drug: APX001 single dose 1; Drug: Matching Placebo
Experimental: Cohort 2; single intravenous dose	Drug: APX001 single dose 2; Drug: Matching Placebo
Experimental: Cohort 3; single intravenous dose	Drug: APX001 single dose 3; Drug: Matching Placebo
Experimental: Cohort 4; single intravenous dose	Drug: APX001 single dose 4; Drug: Matching Placebo
Experimental: Cohort 5; single intravenous dose	Drug: APX001 single dose 5; Drug: Matching Placebo
Experimental: Cohort 6; single intravenous dose	Drug: APX001 single dose 6; Drug: Matching Placebo
Experimental: Cohort 7; multiple intravenous doses	Drug: APX001 multiple dose 1; Drug: Matching Placebo
Experimental: Cohort 8; multiple intravenous doses	Drug: APX001 multiple dose 2; Drug: Matching Placebo
Experimental: Cohort 9; multiple intravenous doses	Drug: APX001 multiple dose 3; Drug: Matching Placebo
Experimental: Cohort 10; multiple intravenous doses	Drug: APX001 multiple dose 4; Drug: Matching Placebo

Outcome Measures

Primary Outcome Measures :

1. 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). [ Time Frame: 21 days ]

Secondary Outcome Measures :

1. Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax). [ Time Frame: 21 days ]
2. Pharmacokinetics of single and multiple doses of APX001 as measured by area under the curve (AUC). [ Time Frame: 21 days ]
3. Pharmacokinetics of single and multiple doses of APX001 as measured by terminal phase half-life (t1/2). [ Time Frame: 21 days ]
4. Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd). [ Time Frame: 21 days ]
5. Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel). [ Time Frame: 21 days ]
6. Pharmacokinetics of single and multiple dose of APX001 as measured by accumulation ratio. [ Time Frame: 21 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Netherlands

PRA Health Sciences

Groningen, Netherlands

Sponsors and Collaborators

Amplyx Pharmaceuticals

Investigators

• Study Director: Michael R Hodges, MD; Amplyx Pharmaceuticals

More Information

• Responsible Party: Amplyx Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02956499
• Other Study ID Numbers: APX001-101
• First Posted: November 6, 2016
• Last Update Posted: August 2, 2017
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Mycoses