Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
| 대상 질환 | Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis |
|---|---|
| 임상 단계 | 1상 |
| 스폰서 | Motric Bio |
| 상태 | 완료 |
| 참여자 수 | 89 명 |
| 중재(약물) | MTR-601 |
| 시작일 | 2023년 9월 11일 |
| 완료일 | 2024년 10월 16일 |
| 결과 공개일 | 2026년 6월 5일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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