BENITIONSClinical Trial Intelligence

Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals

Фаза 1 Завершено NCT06117020

ЗаболеваниеMuscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis
ФазаФаза 1
СпонсорMotric Bio
СтатусЗавершено
Участники89 участн.
ВмешательствоMTR-601
Дата начала11.09.2023
Дата завершения16.10.2024
Публикация результатов5.06.2026

Кратко

To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions. To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601. To evaluate the pharmacodynamic (PD) effects of MTR-601 on muscle strength and muscle accumulation of MTR-601 by muscle biopsy and other potential mechanistic, predictive and PD markers of MTR-601.

Incidence, Severity and Relatedness of Treatment-emergent Adverse Events (TEAEs). TEAE Severity Will be Measured as Mild, Moderate or Severe, and Relatedness Will be Either Related or Not Related.

From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6) · Number of events

Single Ascending Dose Level 1 - Active MTR-6011 Number of events
Single Ascending Dose Level 2 - Active MTR-601 (Fast)0 Number of events
Single Ascending Dose Level 2 - Active MTR-601 (Fed)1 Number of events
Single Ascending Dose Level 3 - Active MTR-6013 Number of events
Single Ascending Dose Level 4 - Active MTR-6012 Number of events
Single Ascending Dose Level 5 - Active MTR-6018 Number of events

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