A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of PLX-4545 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Solid Tumours; Cancer - Any cancer

• Registration Number: ACTRN12623001265662
• Lead Sponsor: Plexium Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-06
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

A participant is eligible for inclusion in this study if all of the following criteria are met:
- Male or female subjects 18 years to 65 years old at the time of informed consent.
- Must have a body mass index of 18.5 to 32.0 kg/m2, inclusive, and weigh at least 50 kg at Screening.
- Must be otherwise healthy and free from illness or disease as determined by medical history, vital signs, physical examinations, ECGs, laboratory studies, and/or other tests performed within 28 days prior to drug administration, as judged by the Investigator.
- Must be able to swallow capsules.
- Must be willing and able to understand the study procedures and comply with all aspects of the protocol and confinement periods.
- Must be able to give signed informed consent and any locally required authorization prior to any protocol-related procedures.

Exclusion Criteria

Participants are not eligible for this study if any of the following criteria apply:
- Has presence or history of hypersensitivity to murine proteins or any drug or other allergies which are considered, in the opinion of the Investigator, to contraindicate study participation.
- Has recently received any vaccination within 12 weeks prior to randomization, or who intends to receive a live vaccination during the study.
- Is known to be seropositive for human immunodeficiency virus (HIV).
- Has a positive result for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen, or antibody to hepatitis C virus (HCV).
- Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest).
- Has previous exposure to antibody therapies within 6 months or administration of immunoglobulins within 6 months prior to study drug administration.
- Has a history of donating 1 unit of blood (450 mL) in the 3 months prior to study drug administration or who intends to donate within 3 months of their last scheduled study visit.
- Has a history of hypertension or a blood pressure >160/90 mmHg at Screening or a history of recurrent hypotensive events considered as clinically relevant or a blood pressure <95/50 mmHg at Screening.
- Is currently taking or who has taken any prescription or non-prescription medication within 7 days of study drug administration including aspirin, dietary or mega dose vitamin supplements, and herbal preparations (except paracetamol, hormone replacement therapies, and/or hormonal contraceptives).
- Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first study drug administration through to study completion, including the Follow-up period.
- Has a history of febrile illness within 5 days prior to the first dose or symptoms of and active infection within 14 days prior to first dose.
- Unable to adhere to the required dietary restrictions
- Criteria, that in the opinion of the investigator, would interfere with the subject's participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of single and multiple doses of PLX-4545 in healthy subjects. This will be done by investigator assessment of the incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).<br>Adverse events will be assessed as defined by CTCAE, Version 5.0. Potential adverse events that may be encountered include changes in kidney function (assessed via blood/urine laboratory tests), deterioration of the lining of the nerves in the body (assessed via neurological examinations) and skin irritation/damage after sun exposure (assessed via physical examinations).[ Adverse events are assessed at screening, on the day prior to first dose (Day -1), then daily while the participant is admitted in the clinical research unit and at the end of study visit (Day 7, Day 24 or Day 14 post-first dose depending on the group participants are enrolled in).]