Trial | NCT02956499  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    apx001 ...

  • Study Participants

    200
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.
Study Started
May 24
2016
Primary Completion
Jul 03
2017
Study Completion
Jul 03
2017
Last Update
Oct 30
2023

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

Cohort 6 Experimental

single intravenous dose

Cohort 7 Experimental

multiple intravenous doses

Cohort 8 Experimental

multiple intravenous doses

Cohort 9 Experimental

multiple intravenous doses

Cohort 1 Experimental

single intravenous dose

Cohort 2 Experimental

single intravenous dose

Cohort 3 Experimental

single intravenous dose

Cohort 4 Experimental

single intravenous dose

Cohort 5 Experimental

single intravenous dose

Cohort 10 Experimental

multiple intravenous doses

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.
No Results Posted