drugset / Trial / NCT05628961
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics
Non-randomizedSequentialOpen-labelTreatment
Summary
The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2025-08-04
- Completion
- 2025-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 100 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 200 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 500 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 1200 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 2500 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 5000 mg | Oral |
| Subject | 3, 4, 3-LI(1, 2-HOPO) | Unknown | 7500 mg | Oral |
Indications
No indication recorded.