Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001255572p
Ethics application status
Submitted, not yet approved
Date submitted
6/11/2015
Date registered
17/11/2015
Date last updated
27/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, and pharmacokinetics of CMX-020 in healthy male and female subjects.
Scientific title
Clinical protocol for a Phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of CMX-020 in healthy male and female subjects.
Secondary ID [1] 287815 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study will be conducted in healthy male and female subjects. CMX-020 is indicated for the treatment of chronic pain. 296692 0
Condition category
Condition code
Other 296928 296928 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo.
The study will consist of Screening (Day -28 to Day -1), Baseline/Check-in Period (Day 1), Treatment Period (Day 1) and Post Treatment/Study Exit (Day 4).

Following randomization, on Treatment Day 1 subjects will be administered a single 15-minute infusion of CMX-020 or placebo according to the computer-generated randomization schedule. All doses will be administered after subjects have fasted for at least six hours. Access to all fluids, including water, will be denied beginning 1 hour prior to dosing.
The dose levels of CMX-020 (mg/kg) for the six cohorts are 0.02, 0.04, 0.08, 0.16, 0.24 and 0.32.

All medications will be administered by the Investigator or appropriately trained healthcare professional in the clinical study unit.
Intervention code [1] 293209 0
Treatment: Drugs
Comparator / control treatment
The comparator/ control for this trial is diluent/placebo which will constitute the inactive ingredients - 20 mL of 20% hydroxypropyl-beta-cyclodextrin in 35% phosphate buffered saline-65% water solution.
The placebo will be administered as an intravenous infusion over 15 minutes on Day 1 only.
Control group
Placebo

Outcomes
Primary outcome [1] 296544 0
1. To evaluate the safety and tolerability of escalating single doses of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects;
Timepoint [1] 296544 0
Subjects will be assessed for AEs and vital signs (blood pressure, pulse, respiration rate, tympanic temperature and oxygen saturation) during the day of dosing and on Day 4 (out-patient visit).
Laboratory assessments (blood and urine) will be assessed on the day of dosing (pre-dose) and on Day 4 (72 hours post-dose)
ECG will be assessed on Day 4
Physical examination will be performed on Day 1 and Day 4
Primary outcome [2] 296545 0
To determine the Maximum Tolerated Dose (MTD) of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects.
Timepoint [2] 296545 0
Safety assessments will be carried out for MTD analysis which include assessments for AEs and vital signs (blood pressure, pulse, respiration rate, tympanic temperature and oxygen saturation) during the day of dosing and on Day 4 (out-patient visit).
Secondary outcome [1] 318719 0
To describe the single-dose pharmacokinetics of escalating doses of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects.
Timepoint [1] 318719 0
Blood assessments will be carried out for PK analysis. Measurements will be taken 16 times throughout the course of the study per subject which include -30 minutes pre-infusion start, and 2, 5, 10, 15, 17, 20, 25, 30, and 45 minutes, and 1,1.5, 2, 2.5, 3, and 4 hours after the start of the infusion.

Eligibility
Key inclusion criteria
- The subject is a healthy adult male or adult female between the ages of 18-50 years, inclusive.
- The subject must weigh at least 50 kg and no more than 90 kg and have a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- The subject must be in good health as determined by a physician. If female, must have a negative urine pregnancy test result at the Screening Visit, and be non-lactating
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- The subject has a history of drug abuse or a history of alcohol abuse within the past 2 years
- The subject has systolic blood pressure > 140 mm Hg or < 85 mm Hg, or diastolic blood pressure > 90 mm Hg or < 60 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods
- The subject has a pulse > 100 beats/minute or < 55 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods
- The subject has active liver disease, jaundice, or an alanine transaminase (ALT) level or aspartate transaminase (AST) level of greater than 1.5 times the upper limit of normal (ULN) during the Pretreatment Screening or Baseline/Check-in Periods

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Randomised, double-blind, placebo-controlled, sequential-panel, ascending single-dose study
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
23/11/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292342 0
Commercial sector/Industry
Name [1] 292342 0
Cytometix Australia Pty Ltd
Country [1] 292342 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cytometix Australia Pty Ltd
Address
c/o Cytometix Inc
9445 Fairway Circle
Bayside, WI 53217 USA
Country
United States of America
Secondary sponsor category [1] 291021 0
None
Name [1] 291021 0
None
Address [1] 291021 0
None
Country [1] 291021 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293807 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 293807 0
129 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 293807 0
Australia
Date submitted for ethics approval [1] 293807 0
14/10/2015
Approval date [1] 293807 0
Ethics approval number [1] 293807 0

Summary
Brief summary
This is a Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of CMX-020 In Healthy Male and Female Subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61142 0
Dr Sepehr Shakib
Address 61142 0
CMAX, a division of Institute of Drug Technology (IDT) Australia Ltd, Level 5, East Wing, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 61142 0
Australia
Phone 61142 0
+61 8 8222 2763
Fax 61142 0
+61 8 8222 2907
Email 61142 0
[email protected]
Contact person for public queries
Name 61143 0
Peggy Tom
Address 61143 0
Cytometix Australia Pty Ltd
c/o Cytometix Inc
9445 Fairway Circle
Bayside, WI 53217 USA
Country 61143 0
United States of America
Phone 61143 0
+1 (414) 745-8000
Fax 61143 0
Email 61143 0
[email protected]
Contact person for scientific queries
Name 61144 0
Peggy Tom
Address 61144 0
Cytometix Australia Pty Ltd
c/o Cytometix Inc
9445 Fairway Circle
Bayside, WI 53217 USA
Country 61144 0
United States of America
Phone 61144 0
+1 (414) 745-8000
Fax 61144 0
Email 61144 0
[email protected]

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No Supporting Document Provided



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