Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
| 対象疾患 | Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis |
|---|---|
| 相 | 第1相 |
| スポンサー | Motric Bio |
| ステータス | 完了 |
| 参加者数 | 89 名 |
| 介入(薬剤) | MTR-601 |
| 開始日 | 2023年9月11日 |
| 完了日 | 2024年10月16日 |
| 結果公開日 | 2026年6月5日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
- A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of — Mapi Pharma Ltd.
- A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patient — Genzyme, a Sanofi Company
- A Study of Oxidative Pathways in MS Fatigue — University of California, San Francisco
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocr — Hoffmann-La Roche
- Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Bioma — Gregory Wu
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocr — Hoffmann-La Roche