Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as (Part A) MKND-201
MKND-201 · 1 trial · 1 indication
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...
MKND-201 is an investigational small molecule being studied for use in healthy volunteers. It is currently in a Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics. The drug is not approved for any medical condition and is in early-stage clinical development.
MKND-201 is being developed by MannKind Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol MNKD. The company is conducting a Phase 1 clinical trial of MKND-201 in healthy volunteers in the United States.
MKND-201 is in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial that enrolls healthy volunteers. The drug has not been approved by regulatory authorities and is still in the early stages of clinical testing.
MKND-201 is being studied in one Phase 1 clinical trial with the identifier NCT06532942. This randomized, double-blind, placebo-controlled trial is evaluating the safety, tolerability, and pharmacokinetics of MKND-201 in healthy volunteers. The trial is enrolling 40 participants aged 40 years and older in the United States.
Yes, MKND-201 is also known as MKND-201 (Part A). The drug is being studied in a Phase 1 clinical trial under this name, which refers to the first part of the clinical development program for this investigational small molecule.