None listed
Conditions
Brief summary
This is a Phase 1 study, first-in-human, double-blind, placebo controlled single ascending dose study of MT-001 evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) dose or single intravenous (IV) dose of MT-001 in adult participants. Participants will be enrolled into five cohorts evaluating five different doses. A total of forty healthy volunteers are planned to be enrolled in this study.
Interventions
This is a phase 1, first-in-human (FIH), double-blind, placebo-controlled single ascending dose study. Approximately 40 adult participants will be randomized 6:2 (MT-001:placebo) in up to 5 planned dosing cohorts of 8 participants each. MT-001 will be administered as single ascending SC or IV doses, with escalation based on emerging safety, tolerability, and PK data following Safety Review Committee review. Participants will be dosed at the study site by qualified site staff, with administrati
This is a phase 1, first-in-human (FIH), double-blind, placebo-controlled single ascending dose study. Approximately 40 adult participants will be randomized 6:2 (MT-001:placebo) in up to 5 planned dosing cohorts of 8 participants each. MT-001 will be administered as single ascending SC or IV doses, with escalation based on emerging safety, tolerability, and PK data following Safety Review Committee review. Participants will be dosed at the study site by qualified site staff, with administration documented to confirm adherence. Each participant will be randomized to only 1 cohort and receive only 1 dose of MT-001 or placebo by SC injection or IV infusion on Day 1. Planned cohorts are as follows: • Dose Group 1 (SC) • Dose Group 2 (SC) • Dose Group 3 (SC) • Dose Group 4 (IV) • Dose Group 5 (IV) Each dosing cohort will commence with a sentinel group of 2 participants, randomized 1:1 to receive MT-001 or placebo.
Sponsors
Mentari 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. Sign the informed consent form (ICF) 2. Healthy adult males and females, 18 to 55 years old (inclusive) at screening. 3. Body mass index (BMI) 18 to 35 kg/m² (inclusive) a body weight < 120 kg at screening 4. Agree to use adequate contraception from screening through end of the study. 5. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visits defined in the protocol
Exclusion criteria
1. Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance. 2. History of illicit drug use or drug abuse or harmful alcohol use 3. Unwilling to abstain from regular, continuous alcohol use (defined as an average of more than 10 standard drinks per week) 4. Volunteer must be a non-smoker (inclusive of nicotine containing products such a vapes or e-cigarettes). 5. History of severe allergic reactions or hypersensitivity 6. Females who are pregnant or breastfeeding, or are planning to become pregnant or breastfeed. 7. Use of investigational drug therapy within 30 days prior to enrollment 8. Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study.
Outcome results
None listed