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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06532942 | A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers | PHASE1 | RECRUITING | 40 | — | — | May 28, 2024 | Oct 31, 2024 | Aug 6, 2024 | 1 | United States |
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose
Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose
Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement
Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement
Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)
Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)
Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)
Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)
Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)
Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)
Changes from baseline in liver enzymes and bilirubin
Changes from baseline in liver enzymes and bilirubin
Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)
Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)
| Arm | Type | Description |
|---|---|---|
| (Part A) MKND-201 SAD | EXPERIMENTAL | Part A involves a Single Ascending Dose (SAD) study with three cohorts. In each cohort, participants will receive a single dose of MKND-201 or placebo for one day. The doses will be categorized as Target Dose, High Dose, and Very High Dose. Allocation is randomized and double-blind, maintaining a ratio of 3:1 (MKND-201:placebo). Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery |
| (Part B) MKND-201 MAD | EXPERIMENTAL | Part B involves a Multiple Ascending Dose (MAD) study with two cohorts. In each cohort, participants will receive MKND-201 or placebo twice daily (BID) at either the Target Dose or High Dose. Allocation is randomized 3:1 (MKND-201:placebo) and double-blind. Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery |
| Placebo | PLACEBO_COMPARATOR | Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort |
| Name | Type | Description |
|---|---|---|
| (Part A) MKND-201 | DRUG | Participants will receive single ascending doses (Target Dose, High Dose, and Very High Dose) of MKND-201 or placebo administered via oral inhalation on Day 1 |
| Placebo | DRUG | Participants will receive matching placebo across Part A and Part B of the study. |
| (Part B) MKND-201 | DRUG | Participants will receive multiple ascending doses (Target Dose and High Dose) of MKND-201 or placebo administered via oral inhalation, twice daily, from Day 1 to Day 7 |
Key Inclusion Criteria: * Is ≥40 and ≤65 years of age at the time of signing the informed consent form. * Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24...