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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
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
Secondary ID [1] 309457 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Life threatening infectious disease 329711 0
Urinary Tract Infection 329712 0
Condition category
Condition code
Infection 326609 326609 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325879 0
Treatment: Drugs
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)
Control group
Dose comparison

Outcomes
Primary outcome [1] 334467 0
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.
Timepoint [1] 334467 0
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.
Primary outcome [2] 334581 0
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.
Timepoint [2] 334581 0
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.
Secondary outcome [1] 420795 0
To evaluate the concentration of RECCE®327 in urine at different doses and infusion rates
Timepoint [1] 420795 0
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.
Secondary outcome [2] 421288 0
To evaluate ex vivo pharmacodynamics (MIC) of urine and blood from healthy male and female volunteers.
Timepoint [2] 421288 0
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.

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2023
Actual
15/06/2023
Date of last participant enrolment
Anticipated
16/10/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
16
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 24522 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 25086 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 40755 0
2031 - Randwick
Recruitment postcode(s) [2] 40111 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313652 0
Commercial sector/Industry
Name [1] 313652 0
Recce Pharmaceuticals Ltd
Country [1] 313652 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Recce Pharmaceuticals Ltd
Address
Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 315446 0
None
Name [1] 315446 0
Address [1] 315446 0
Country [1] 315446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312820 0
Bellberry Human Research ethics Committee
Ethics committee address [1] 312820 0
123 Glen Osmond Road Eastwood, South Australia 5063
Ethics committee country [1] 312820 0
Australia
Date submitted for ethics approval [1] 312820 0
14/12/2022
Approval date [1] 312820 0
13/04/2023
Ethics approval number [1] 312820 0
2022-12-1346

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126034 0
Dr Nicholas Farinola
Address 126034 0
CMAX Clinical Research
Level 5, 18a North Terrace, Adelaide, SA 5000
Country 126034 0
Australia
Phone 126034 0
+61 421 570 586
Fax 126034 0
Email 126034 0
nicholas.farinola@sa.gov.au
Contact person for public queries
Name 126035 0
Mrs Janice Lan
Address 126035 0
Recce Pharmaceuticals Ltd
suite 10, 3 Brodie Hall Drive Technology Park Bentley WA 6102
Country 126035 0
Australia
Phone 126035 0
+61 8 9362 9860
Fax 126035 0
Email 126035 0
janice.lan@recce.com.au
Contact person for scientific queries
Name 126036 0
Mrs Janice Lan
Address 126036 0
Recce Pharmaceuticals Ltd
suite 10, 3 Brodie Hall Drive Technology Park Bentley WA 6102
Country 126036 0
Australia
Phone 126036 0
+61 8 9362 9860
Fax 126036 0
Email 126036 0
janice.lan@recce.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.