drugset / Trial / NCT06218784
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
RandomizedSequentialQuadruple-blindTreatment
Summary
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.
Timeline
- Start
- 2022-11-11
- Primary completion
- 2024-07-29
- Completion
- 2024-07-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iN1011-N17 | Unknown | 100 mg | Oral |
| Subject | iN1011-N17 | Unknown | 200 mg | Oral |
| Subject | iN1011-N17 | Unknown | 400 mg | Oral |
| Subject | iN1011-N17 | Unknown | 800 mg | Oral |