A Phase 1, Randomized, Placebo-Controlled, Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PLX-4545 in Healthy Subjects

Plexium Australia Pty Ltd0 sites96 target enrollmentDecember 6, 2023

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 6, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Plexium Australia Pty Ltd

Eligibility Criteria

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).