NCT05496205

A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Single- Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics Properties of iN1011-N17 After Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: iN Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.

Conditions

• Osteoarthritis
• Pain
• Post Herpetic Neuralgia
• Neuropathic Pain
• Chronic Pain
• Nav 1.7

Interventions

Type	Name	Description
DRUG	iN1011-N17	This study will be conducted in approximately 104 healthy subjects in up to 13 sequential dose cohorts. Thirteen cohorts will consist of up to 8 subjects, including 2 subjects receiving placebo and 6 subjects receiving iN1011-N17. Each subsequent cohort will continue to be randomized and dosed until maximum exposure is attained or a stopping criterion has been reached.
DRUG	Placebo	Matching Placebo for each formulations

Timeline

• Start date: 2020-09-30
• Primary completion: 2023-10-08
• Completion: 2023-10-08
• First posted: 2022-08-11
• Last updated: 2024-06-21

Locations

1 site across 1 country: Australia