None listed
Conditions
Brief summary
- This study will test a new investigational medicine called MAR005 in healthy adult volunteers. - The purpose is to find out whether MAR005 is safe and well tolerated when given multiple times. -Researchers will also study how the body absorbs, distributes, and removes the medicine, and how the medicine affects the body. -Participants will be randomly assigned to receive either MAR005 or a MAR001 and neither the participants nor the study team will know which treatment is being given during the study.
Interventions
Up to 6 healthy participants will be receiving MAR005.
MAR005 is a monoclonal antibody designed to block angiopoietin-like 4. MAR005 is structurally identical to MAR001 aside from two additional amino acid substitutions in the Fc domain of MAR005 that are designed to improve the half-life of the drug.
Investigational product: 300 mg dose of MAR005 for subcutaneous (SC) injection administered by site staff on Day 1 and Day 29. Dosing will be staggered with 1 participant from the MAR005 arm dos
Up to 6 healthy participants will be receiving MAR005. MAR005 is a monoclonal antibody designed to block angiopoietin-like 4. MAR005 is structurally identical to MAR001 aside from two additional amino acid substitutions in the Fc domain of MAR005 that are designed to improve the half-life of the drug. Investigational product: 300 mg dose of MAR005 for subcutaneous (SC) injection administered by site staff on Day 1 and Day 29. Dosing will be staggered with 1 participant from the MAR005 arm dosed at least 47 hours before the remaining participants. Participants will be screened within 28 days before their first dose of trial intervention. They will reside in the Clinical Unit from the day before dosing until the day after dosing for each dosing instance. Safety assessments will be conducted throughout the trial, and participants will attend 11 outpatient visits. Adherence to the intervention will be monitored through direct administration of all doses by qualified study personnel at the Clinical Research Unit. Dosing will be documented in source records and drug accountability records, and participants will be monitored according to the protocol-defined schedule.
Sponsors
Marea Therapeutics, Inc
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. BMI in the range 18.0 to 32.0 kg/m2 (inclusive). 2. In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 3. Body weight more than 50 kg 4. Negative pregnancy test at screening and admission (female participants only). 5. Stable diet (as judged by the Investigator) for a minimum of 3 months prior to screening and with no plans to change diet through the duration of the trial.
Exclusion criteria
1. Use of/unable to refrain from using prescription medication (except hormonal contraception and hormone replacement therapy [HRT]), including vaccination, from 14 days before first administration of trial intervention until the end of the trial. 2. Use of/unable to refrain from using non-prescription drugs or supplements (with exception of standard dose multivitamins and occasional paracetamol [acetaminophen] use) from 7 days before first administration of trial intervention until the end of the trial. 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) more than or equal to 1.5 × upper limit of normal (ULN) at screening and/or Day –1. A repeat is allowed on 1 occasion for determination of eligibility. One retest is allowed at the Investigator’s discretion. 4. Regularly smoking more than 10 cigarettes per week or equivalent use of any other nicotine product, and/or unwilling to abstain from smoking or using other nicotine products during dosing visits. 5. History of anaphylaxis or other significant allergy in the opinion of the Investigator. 6. Use of any monoclonal antibody therapy in the 6 months before screening, or history of hypersensitivity to any monoclonal antibody, or to any of the excipients used in the trial interventions 7. History of cancer within 3 years of screening 8. Positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody.
Outcome results
None listed