NCT06558656

Effect of Food of NTQ5082 in Healthy Subjects

A Randomized, Open Label, Two Sequence, Two Period, Double Crossover-design Phase I Clinical Trial of NTQ5082 Capsules Taken by Healthy Subjects on an Empty Stomach (i.e, Fasting) as Well as After a Meal (i.e. Fed)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral administration of NTQ5082 capsules and the safety and tolerability of single oral administration of NTQ5082 capsules on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy subjects

Conditions

• Complement-mediated Hemolytic Diseases

Interventions

Type	Name	Description
DRUG	NTQ5082 capsule	Part 1:The subjects are orally administered NT5082 capsules on an empty stomach in the first cycle and after a meal in the second cycle. Part 2:The subjects are orally administered NT5082 capsules after a meal in the first cycle and on an empty stomach in the second cycle.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

1 site across 1 country: China