A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Single Ascending Dose Study of MT-001 in Adult Participants

INTERVENTION: 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. CONDITION: Migraines; ; Migraines Neurological ‐ Other neurological disorders PRIMARY OUTCOME: To evaluate the safety and tolerability of a single MT‐001 injection (either subcutaneous or intravenous. This will be assessed as a composite outcome.[Incidence of treatment‐emergent adverse events (TEARs).; Incidence, type, severity, and relationship of treatment‐emergent adverse events (TEAEs) will be assessed separately.; ; The possible AEs are: General reactions (e.g. headache, fever), injection site reactions (e.g. pain, redness), allergic reactions (e.g. rash); ; Changes in vital signs, blood pressure measured using Sphygmomanometer, Heart Rate and Oxygen saturation measured using a Multiparameter patient monitor, temperature using thermometer.; ; Physical examinations include general appearance, head, eyes, ears, nose, throat, neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, and other.; ; Outcomes will be collected through clinical assessments performed by the investigator (or delegate).; TEARs, Physical exam, Vital signs will be assessed at each scheduled visit post dose. Day 1 post dose, Day 2, Day 3, Day 4, Day 7, Day 15, Day 28, Day 56, Day 84, Day 168, Day 252 and Day 335.] 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 inde X(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 SECONDARY OUTCOME: To characterize the PK profile of MT‐001 after single SC or IV doses in adult participants[PK parameters to be evaluated after MT‐001 administration include (but are not limited to): ; • Maximum observed concentration (Cmax) ; • Time to Cma X(Tmax) ; • Area under the concentration‐time curve from time 0 to time t (AUC0‐t) ; • Area under the concentration‐time curve from time 0 to the last measurable concentration (AUClast) ; • Half‐life (T1/2) ; • Clearance (Cl) ; • Volume of distribution (Vz) ; • Area under the concentration‐time curve from time 0 to infinity (AUCinf) ; • Comparison of dose proportionality and exposure between SC and IV formulations PK testing will take place at the following timepoints: Day 1, Day 2, Day 3, Day 4, Day 7, Day 15, Day 28, Day 56, Day 84, Day 168, Day 252 and Day 335.]