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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04759807 | A Phase 1b Study of PUR1800 in Patients With COPD | PHASE1 | COMPLETED | 18 | — | — | Jan 4, 2021 | Dec 2, 2021 | Jun 27, 2022 | 1 | United Kingdom |
Review of adverse events
Review of spirometry data
Breaths per minute
Systolic pressure over diastolic pressure
Beats per minute
As a percentage
Medical record review
Physician's notes
Lab reports with any out of range results flagged
ECG report and tracing
Review of spirometry data
Review of concomitant medications administered
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 250 μg | ACTIVE_COMPARATOR | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 500 μg | ACTIVE_COMPARATOR | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| Name | Type | Description |
|---|---|---|
| Placebo Comparator | DRUG | The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 250 ug | DRUG | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 500 ug | DRUG | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
Inclusion Criteria: Patients must meet all the following: 1. Male or female patients aged 40 to 75 years of age with a body mass index ≥ 17 and ≤ 35 kg/m2. 2. Female patients must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control metho...