NCT06560593

A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (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, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK/PD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.

Conditions

• Complement-mediated Hemolytic Diseases

Interventions

Type	Name	Description
DRUG	NTQ5082	single ascending dose, randomized, double-blind study，with 8 dose groups preset. The first cohort will be the sentinel group, consisted of 2 subjects receiving NTQ5082 capsules. The remaining cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.
DRUG	Placebo	multiple ascending dose, randomized, double-blind study，with 3 dose groups preset. All cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.

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