A study to compare safety, tolerability, and how the body processes a powdered penicillin injection (Extencilline®) given into the muscle or under the skin in healthy adults

Exclusion Criteria18

• Participants who meet any of these criteria are not eligible for participation in the trial:
• Currently taking penicillins or use of any penicillin-based antibiotics from screening through to the subsequent dosing visits. The use of probenecid, and non-steroidal anti-inflammatory drugs, or other medications which may significantly alter BPG PK will also not be permitted within 14 days prior to study drug administration until completion of the final follow-up visit, with the exception of occasional paracetamol and ibuprofen use.
• Concurrent participation in another clinical trial.
• Planned operation/absence during the follow-up duration of the study.
• Known or prior documented penicillin allergy.
• Known or documented immediate hypersensitivity (anaphylaxis) to another beta-lactam antibiotic agent (cephalosporins, monobactam, carbapenems).
• Known allergy to soy or peanuts (An excipient of powdered BPG).
• Known or prior documented allergy to lidocaine (local anaesthetic agent).
• Presence of significant abnormalities in complete blood count, as assessed by the investigator or designee.
• Presence of significant abnormal renal function, as assessed by the investigator or designee.
• Presence of significant liver dysfunction, as assessed by the investigator or designee.
• Existing dermatological conditions or other abnormalities (e.g., extensive scarring from significant hip/gluteal surgery/radiotherapy) that may affect skin and subcutaneous tissue integrity at the site of injection, especially abdomen, buttocks or loins.
• Use of any prescription medication or over-the-counter medication (except for oral paracetamol up to 4g/24 hours; oral, parenteral or implanted hormonal contraception in women of child bearing potential), herbal products, vitamins or minerals, within 7 days prior to study drug administration until completion of the final follow-up visit, unless in the opinion of the PI or delegate the medication will not compromise participant safety or interfere with study procedures or data validity.
• Participants who are unable or unwilling to avoid nicotine use during confinement periods.
• History of alcohol or drug abuse in the past 12 months prior to screening, or participants who are positive for Urine drug screen (UDS) and alcohol breath test (ABT) at screening or prior to dosing (Repeat testing as per the investigator (or designee) discretion).
• Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 40-100 beats/min.
• Participants who have received any study drug within 30 days or 5 half-lives, whichever is longer prior to screening.
• Any other reason which in the opinion of the Principal Investigator would compromise participant safety, or interfere with study procedures or data validity.