Last reviewed · How we verify
Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
Details
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 72 |
| Start date | 2024-12-03 |
| Completion | 2025-09 |
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Interventions
- TQC3721 inhalation powder
- Placebo for TQC3721 inhalation powder
Primary outcomes
- Adverse events (AE) — 19 days
Incidence of adverse events (AE) - Serious Adverse Events (SAE) — 19 days
Incidence of Serious Adverse Events (SAE) - Treatment-emergent adverse events (TEAEs) — 19 days
Incidence of treatment-emergent adverse events (TEAEs)
Countries
China