Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
| 适应症 | Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis |
|---|---|
| 分期 | 1期 |
| 申办方 | Motric Bio |
| 状态 | 已完成 |
| 受试者人数 | 89 人 |
| 干预（药物） | MTR-601 |
| 开始日期 | 2023年9月11日 |
| 完成日期 | 2024年10月16日 |
| 结果公布日 | 2026年6月5日 |
摘要
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.
| Single Ascending Dose Level 1 - Active MTR-601 | 1 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-601 | 3 Number of events |
| Single Ascending Dose Level 4 - Active MTR-601 | 2 Number of events |
| Single Ascending Dose Level 5 - Active MTR-601 | 8 Number of events |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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