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Trial registered on ANZCTR
Registration number
ACTRN12623000448640
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
2/05/2023
Date last updated
7/07/2023
Date data sharing statement initially provided
2/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
An Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 Intravenous Dose and Infusion Rates
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Scientific title
An Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 Intravenous Dose and Infusion Rates
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Secondary ID [1]
309457
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Life threatening infectious disease
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Urinary Tract Infection
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Condition category
Condition code
Infection
326609
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study consists up to 4 cohorts with 4 participants at each dose level. Each participant will begin with a single dose with RECCE®327 intravenously over Period A (longer infusion duration), followed by 48 hours safety surveillance and PK data collection. The second dose of RECCE®327 infusion over Period B (shorter infusion duration) with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose.
For the subsequent cohort, a non-Data Safety Monitoring Board (DSMB) committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and/ or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well. There will be 4 scheduled non-DSMB committee meetings and are planned one week after the occurrence of Period B of the last participant at each Cohort. Ad hoc meeting maybe requested by the safety committee chair, PI or any member feel the sense of necessity.
Cohort 1:
Period A- 2500 mg RECCE®327 for 45 minutes intravenous infusion
Period B- 2500 mg RECCE®327 for 30 minutes intravenous infusion
Cohort 2 to 4: Including Period A and Period B with ranging below:
- dose ranging from 2000 mg to 3000 mg
- infusion duration ranging between 15 minutes to 45 minutes
- RECCE®327 concentration ranging from 4 mg/mL to 8 mg/mL
Each individual diluted infusion bag of RECCE®327 will be sending representative sample to bioanalytical lab for analysis to ensure the correct dose are given to participants at each Cohort.
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Intervention code [1]
325879
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Treatment: Drugs
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Comparator / control treatment
RECCE®327 administrated intravenously over 60 minutes with dose ranging from 50 mg to 6000 mg of dose concentration of 8 mg/mL. (Reference from RECCE327-001 Clinical Trial)
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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To evaluate the safety/ tolerability of RECCE®327 doses ranging from 2000 to 3000 mg at infusion rates ranging from 15 to 45 minutes in healthy male and female volunteers.
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Assessment method [1]
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Timepoint [1]
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Period A will be dosed on Day 1 while Period B will be dosed on Day 3.
Vital signs include blood pressure, heart rate and tympanic temperature will be measured for both at Period (Day 1 and Day 3) Pre-dose, post dose and 4 hours post Start of Infusion; Day 2, Day 4, Day 5 and Day 10 (End of Study). standard clinical vital signs monitor will be used for this study at study site.
Physical Examinations will be measured at screening, day -1, day 5 and Day 10 (EOS), or symptoms directed during study period.
Targeted Infusion site Physical Exam will be measured for both arms at Screening, Day -1, Day 2, Day 4, Day 5 and Day 10.
Infusion site pain and tolerability assessment will be measured pre-dose (30mins prior infusion), 15 mins, 30 mins, 45 mins, 60 mins and 12 hours from the start of infusion on day 1 and Day 3 by using 11- points Pain intensity- Numeric Rating Scale (PI-NRS).
Clinical Laboratory blood sample will be collected at screening, Day -1, Day 2, Day 5 and Day 10.
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Primary outcome [2]
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To evaluate the plasma pharmacokinetics of RECCE®327 using doses ranging from 2000 to 3000 mg at infusion rates ranging from 15-45 minutes in healthy male and female volunteers.
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Assessment method [2]
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Timepoint [2]
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Plasma Pharmacokinetics timepoint collection are depending on infusion duration:
45 minutes infusion duration plasma PK timepoints:
-30 minutes, 5, 10, 15, 20, 25, 35, 45, 50, 60, 75, 90,120, 150, 180, 210, 240, 300, 360, 480, 600, 720, 960, 1440 minutes from Strat of infusion
30 minutes infusion duration plasma PK timepoints:
-30 minutes, 5, 10, 15, 20, 30, 35, 45, 50, 60, 75, 90,120, 150, 180, 210, 240, 300, 360, 480, 600, 720, 960, 1440 minutes from Strat of infusion
15 minutes infusion duration plasma PK timepoints:
-30 minutes, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90,120, 150, 180, 210, 240, 300, 360, 480, 600, 720, 960, 1440 minutes from Strat of infusion
Urine Pharmacokinetics timepoint collection are for all Periods:
Pre-dose, 0-15 minutes, 15- 30 minutes, 30-45 minutes, 45-60 minutes, 60-75 minutes, 75-90 minutes, 90-120 minutes, 120-240 minutes, 240-360 minutes. All sample must be collected via urinary IDC (indwelling catheter) and remain sample at refrigerated condition at all times.
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Secondary outcome [1]
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To evaluate the concentration of RECCE®327 in urine at different doses and infusion rates
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Assessment method [1]
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Timepoint [1]
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Urine collection timepoints are for all Periods:
Pre-dose, 0-15 minutes, 15- 30 minutes, 30-45 minutes, 45-60 minutes, 60-75 minutes, 75-90 minutes, 90-120 minutes, 120-240 minutes, 240-360 minutes. All sample must be collected via urinary IDC (indwelling catheter) and remain sample at refrigerated condition at all times.
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Secondary outcome [2]
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To evaluate ex vivo pharmacodynamics (MIC) of urine and blood from healthy male and female volunteers.
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Assessment method [2]
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Timepoint [2]
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Urine MIC sample collection timepoints are for all Periods:
Pre-dose, 0-15 minutes, 15- 30 minutes, 30-45 minutes, 45-60 minutes, 60-75 minutes, 75-90 minutes, 90-120 minutes, 120-240 minutes, 240-360 minutes. All sample must be collected via urinary IDC (indwelling catheter) and remain sample at refrigerated condition at all times.
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Eligibility
Key inclusion criteria
• Healthy males and females, aged 18-65 (inclusive) at screening with suitability confirmed by way of screening assessments.
• Body mass index (BMI) between 18 and 35 kg/m² (inclusive) and body weight not less than 50 kg and no more than 120kg.
• Women of childbearing potential (WOCBP) must agree to follow instructions for highly effective contraceptive method(s) of contraception for the duration of treatment with study drug plus 30 days after the last study drug administration.
• Must agree to urethral catheterisation of the bladder for each dosing period which will be placed 2 hours pre dose and removed at 6 hours post dose.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
• Currently pregnant or breastfeeding women.
• History or current phlebitis or thrombophlebitis.
• History or current clinically significant medical history or condition.
• Use of any investigational products within 30 days prior first dose of RECCE®327.
• Alcohol or substance abuse within the past 6 months prior to screening.
• Receipt of any vaccination within 14 days prior the first study dose administration.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A formal statistical analysis plan (SAP) will be prepared. All statistical reporting for the safety data will be performed using the validated statistical software SAS® Version 9.3 or higher (SAS Institute, Inc., Cary, NC, USA). Data collected from participants who received at least one dose of RECCE®327 will be presented in data listings. Both absolute values and change from Baseline (pre dose) values for each participant will be given where applicable. Data listings will be sorted by treatment group, participant number, and time point.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
29/05/2023
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Actual
15/06/2023
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Date of last participant enrolment
Anticipated
16/10/2023
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Actual
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Date of last data collection
Anticipated
31/10/2023
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Actual
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Sample size
Target
16
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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CMAX Clinical Research Pty Ltd - Adelaide
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Recruitment hospital [2]
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Scientia Clinical Research - Randwick
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
40755
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Recce Pharmaceuticals Ltd
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Address [1]
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Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Recce Pharmaceuticals Ltd
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Address
Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
315446
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research ethics Committee
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Ethics committee address [1]
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123 Glen Osmond Road Eastwood, South Australia 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/12/2022
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Approval date [1]
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13/04/2023
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Ethics approval number [1]
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2022-12-1346
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Summary
Brief summary
Single centre, adaptive design, open-label, two period crossover, study to evaluate the safety, pharmacokinetics and ex vivo antibacterial effects of RECCE®327 in healthy male and female volunteers.
This study consists up to 4 cohorts with 4 participants at each dose level. The first cohort will involve two infusion rates 45 minutes (Period A) and 30 minutes (Period B) of RECCE®327 at a concentration of 4 mg/ml. Each participant will begin with a single dose with RECCE®327 intravenously over 45 minutes, followed by 48 hours safety surveillance and PK data collection. Safety assessments will be performed by the investigational site study staff and reviewed (sign off) by the PI or designee before the second dose of RECCE®327 infusion over 30 minutes with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose.
For the subsequent cohort, a non-DSMB committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and / or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well.
the aim of this study is to investigate possible safety dose of RECCE®327 in various dose levels and infusion duration.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicholas Farinola
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Address
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CMAX Clinical Research
Level 5, 18a North Terrace, Adelaide, SA 5000
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Country
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Australia
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Phone
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+61 421 570 586
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Janice Lan
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Address
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Recce Pharmaceuticals Ltd
suite 10, 3 Brodie Hall Drive Technology Park Bentley WA 6102
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Country
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Australia
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Phone
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+61 8 9362 9860
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Janice Lan
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Address
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Recce Pharmaceuticals Ltd
suite 10, 3 Brodie Hall Drive Technology Park Bentley WA 6102
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Country
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Australia
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Phone
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+61 8 9362 9860
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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