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Study of MKND-201 in Healthy Volunteers

This study is testing a new inhaled drug called MKND-201 in healthy volunteers. The main goals are to see how safe it is, how well people tolerate it, and how the body processes it (pharmacokinetics). You might receive MKND-201 or a placebo (an inactive substance) through an inhaler. Some participants will receive a single dose, while others will receive multiple doses over several days. The study is looking for any side effects from the inhaler or changes in lung function. To join, you must be between 40 and 65 years old and meet other health requirements. The study plans to enroll 40 healthy volunteers.

Study design
This is a Phase 1, first-in-human study that is randomized and double-blind, meaning neither you nor the study staff will know if you are receiving MKND-201 or placebo. It involves about 40 healthy adult participants.
What's involved
You will receive MKND-201 or placebo via oral inhalation, either as a single dose or twice daily for seven days. You will also have tests to check for inhaled intolerability and lung function.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for up to 9 days after a single dose, or up to 15 days after multiple doses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06532942

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

UNKNOWN
PHASE1Ages 40–65InterventionalTreatment
Mannkind Corporation
~40 participants
Updated 2024-08-06 on ClinicalTrials.gov
What's tested:(Part A) MKND-201Placebo(Part B) MKND-201

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
(Part A) Incidence of inhaled intolerability
Measured over Up to Day 9 (+/- 3 days)
+15 more outcomes measured

Conditions

Healthy Volunteers

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Healthy Volunteers

NCT06532942

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Flourish Research

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jennifer Pleitez
[email protected]
818-661-5000
Email the study team

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Eligibility criteria

Inclusion

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 hours before urine drug screening because this can falsify 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.

Exclusion

Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)
Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, 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 alanine aminotransferase \[ALT\] \> 1.5 × ULN) at screening.
Has renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2), 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 use over the last 2 years (by self-declaration).

What this trial measures

  • (Part A) Incidence of inhaled intolerabilityUp to Day 9 (+/- 3 days)

    Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)

  • (Part B) Incidence of inhaled intolerabilityUp to Day 15 (+/- 3 days)

    Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)

  • (Part A) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdoseUp to Day 9 (+/- 3 days)

    Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose

  • (Part B) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdoseUp to Day 15 (+/- 3 days)

    Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose

  • (Part A) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurementUp to Day 9 (+/- 3 days)

    Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement

  • (Part B) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurementUp to Day 15 (+/- 3 days)

    Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement

  • (Part A) Incidence of treatment-emergent adverse events (TEAEs)Up to Day 9 (+/- 3 days)

    Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)

  • (Part B) Incidence of treatment-emergent adverse events (TEAEs)Up to Day 15 (+/- 3 days)

    Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)

  • (Part A) Incidence of serious adverse events (SAEs)Up to Day 9 (+/- 3 days)

    Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)

  • (Part B) Incidence of serious adverse events (SAEs)Up to Day 15 (+/- 3 days)

    Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)

  • (Part A) Incidence of abnormal clinically significant vital signsUp to Day 9 (+/- 3 days)

    Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)

  • (Part B) Incidence of abnormal clinically significant vital signsUp to Day 15 (+/- 3 days)

    Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)

  • (Part A) Changes from baseline in liver enzymes and bilirubinUp to Day 9 (+/- 3 days)

    Changes from baseline in liver enzymes and bilirubin

  • (Part B) Changes from baseline in liver enzymes and bilirubinUp to Day 15 (+/- 3 days)

    Changes from baseline in liver enzymes and bilirubin

  • (Part A) Changes from baseline in coagulation parameters, INR and aPTTUp to Day 9 (+/- 3 days)

    Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)

  • (Part B) Changes from baseline in coagulation parameters, INR and aPTTUp to Day 15 (+/- 3 days)

    Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)