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Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956499
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 6, 2016
Last Update Posted Date August 2, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax). [ Time Frame: 21 days ]
  • Pharmacokinetics of single and multiple doses of APX001 as measured by area under the curve (AUC). [ Time Frame: 21 days ]
  • Pharmacokinetics of single and multiple doses of APX001 as measured by terminal phase half-life (t1/2). [ Time Frame: 21 days ]
  • Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd). [ Time Frame: 21 days ]
  • Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel). [ Time Frame: 21 days ]
  • Pharmacokinetics of single and multiple dose of APX001 as measured by accumulation ratio. [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fungal Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 1
    • Drug: Matching Placebo
  • Experimental: Cohort 2
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 2
    • Drug: Matching Placebo
  • Experimental: Cohort 3
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 3
    • Drug: Matching Placebo
  • Experimental: Cohort 4
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 4
    • Drug: Matching Placebo
  • Experimental: Cohort 5
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 5
    • Drug: Matching Placebo
  • Experimental: Cohort 6
    single intravenous dose
    Interventions:
    • Drug: APX001 single dose 6
    • Drug: Matching Placebo
  • Experimental: Cohort 7
    multiple intravenous doses
    Interventions:
    • Drug: APX001 multiple dose 1
    • Drug: Matching Placebo
  • Experimental: Cohort 8
    multiple intravenous doses
    Interventions:
    • Drug: APX001 multiple dose 2
    • Drug: Matching Placebo
  • Experimental: Cohort 9
    multiple intravenous doses
    Interventions:
    • Drug: APX001 multiple dose 3
    • Drug: Matching Placebo
  • Experimental: Cohort 10
    multiple intravenous doses
    Interventions:
    • Drug: APX001 multiple dose 4
    • Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2017)
120
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
80
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956499
Other Study ID Numbers  ICMJE APX001-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amplyx Pharmaceuticals
Study Sponsor  ICMJE Amplyx Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael R Hodges, MD Amplyx Pharmaceuticals
PRS Account Amplyx Pharmaceuticals
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP