NCT04720443

A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects

A Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: The National Institutes of Pharmaceutical R&D Co. Ltd, China · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the safety and tolerability of single ascending and multiple ascending oral doses of NIP292 tablets administered following an overnight fast in healthy adult subjects.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	NIP292 tablet	NIP292 (oral tablet at 10 mg) or placebo
DRUG	NIP292 tablet	NIP292 (oral tablet at 30 mg) or placebo
DRUG	NIP292 tablet	NIP292 (oral tablet at 100 mg) or placebo
DRUG	NIP292 tablet	NIP292 (oral tablet at 300 mg) or placebo
DRUG	NIP292 tablet	NIP292 (oral tablet at 500 mg) or placebo
DRUG	NIP292 tablets	NIP292 (oral tablet at dosage 1) or placebo
DRUG	NIP292 tablets	NIP292 (oral tablet at dosage 2) or placebo

Timeline

• Start date: 2019-11-22
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2021-01-22
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study