Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04027439 | Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler | PHASE2 | COMPLETED | 37 | — | — | Dec 10, 2018 | May 23, 2019 | Sep 26, 2022 | 1 | United States |
RPL554 Plasma pharmacokinetics AUC0-12 (Area under the Curve) after single dose
RPL554 Area under the curve at maximum concentration after a single dose
RPL554 Plasma pharmacokinetics Half-life concentration after a single dose
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) on Day 7
| Arm | Type | Description |
|---|---|---|
| Part A: RPL554 | ACTIVE_COMPARATOR | Placebo controlled, parallel group single dose. Five of the 6 treatment arms will be double-blind and one will be single-blind |
| Part B: RPL554 | ACTIVE_COMPARATOR | Double-blind, placebo-controlled, complete block cross-over |
| Name | Type | Description |
|---|---|---|
| Part A: RPL554 | DRUG | 1 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler |
| Part B: RPL554 | DRUG | Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A |
| Placebos | DRUG | Part A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler. Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A. |
Inclusion Criteria: 1. Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. 2. For males, not to donate sperm and either be sexually abstinent or use contraception as specified by the protocol....