A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers

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 atscreening and upon admission to the CRU on Day -1. Note: Participants should notconsume poppy seeds within 24 hours before urine drug screening because this canfalsify the results of the opiate urine drug test.

• Is willing to adhere to the restrictions and requirements specified in the protocol.

• Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.

• Is capable of performing spirometry, as required by the study procedures.

Key Exclusion Criteria:

• Has a history of significant lung disease (e.g., pulmonary fibrosis, cysticfibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lowerrespiratory tract infection in the prior 8 weeks, history of lung surgery orprocedure, etc.)

• Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heartdisease, GI disease, or history of any psychotic mental illness.

• Has a history of hepatic disease or has abnormal liver function tests (i.e.,aspartate aminotransferase [AST] > 1.5 × upper limit of normal [ULN] or alanineaminotransferase [ALT] > 1.5 × ULN) at screening.

• Has renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI),at screening.

• Has any history of pulmonary malignancy.

• Has a history of substance abuse or dependency or history of recreational drug useover the last 2 years (by self-declaration).