RecruitingPhase 1ACTRN12623000448640

An Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 Intravenous Dose and Infusion Rates

Sponsor

Recce Pharmaceuticals Ltd

Enrollment

16 participants

Start Date

Jun 15, 2023

Study Type

Interventional

Conditions

Life threatening infectious disease Urinary Tract Infection

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria4

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.

Exclusion Criteria6

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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Interventions

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.