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

Phase 1

Recruiting

• Conditions: ife threatening infectious disease; Urinary Tract Infection; Life threatening infectious disease; Infection - Other infectious diseases

• Registration Number: ACTRN12623000448640
• Lead Sponsor: Recce Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-02
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

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.

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

• Study Type: Interventional
• Study Design: Not specified