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

Plain Language Summary

Simplified for easier understanding

RECCE 327 is an experimental antibiotic being developed as a potential new weapon against drug-resistant bacterial infections. Before it can be tested in patients who are sick, researchers need to understand how the body processes it — including the safest dose and how quickly it can be given by drip (intravenous infusion). This Phase 1 study will give RECCE 327 to healthy volunteers in up to four groups, testing different infusion rates (45 minutes versus 30 minutes) and potentially different dose levels. Each participant will receive the drug twice — once at each infusion speed — with at least 48 hours in between for safety monitoring and blood tests. A urinary catheter will be placed briefly around each dose to collect urine samples. You may be eligible if you are a healthy adult aged 18–65, are not pregnant or breastfeeding, and have no significant medical conditions. Participants must agree to bladder catheterisation during each dosing period and must not have used any prescription medications in the four weeks before the study (with some exceptions). You should not be at risk of HIV infection.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.