Healthy VolunteersPhase 1NCT06532942
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
A Phase 1 study testing (Part A) MKND-201 and (Part B) MKND-201 in people with Healthy Volunteers, run by Mannkind Corporation at 1 site in United States.
Trial summary
MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- (Part A) MKND-201 and (Part B) MKND-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Flourish Research
San Antonio, Texas, 78229
Sierra Wilson, 210-949-0122 ext. 208, SWilson@flourishresearch.com
Douglas Denham, DO
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers
MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- (Part A) MKND-201, Placebo, (Part B) MKND-201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Part A) MKND-201Drug
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
PlaceboDrug
Participants will receive matching placebo across Part A and Part B of the study.
(Part B) MKND-201Drug
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
| Study group | Role | What they receive |
|---|---|---|
| (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 Receives: Drug: (Part A) MKND-201 |
| (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 Receives: Drug: (Part B) MKND-201 |
| Placebo | Placebo comparator | Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A) Incidence of inhaled intolerability
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Measured: Up to Day 9 (+/- 3 days)
(Part B) Incidence of inhaled intolerability
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Measured: Up to Day 15 (+/- 3 days)
(Part A) 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
Measured: Up to Day 9 (+/- 3 days)
(Part B) 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
Measured: Up to Day 15 (+/- 3 days)
(Part A) 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
Measured: Up to Day 9 (+/- 3 days)
(Part B) 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
Measured: Up to Day 15 (+/- 3 days)
(Part A) Incidence of treatment-emergent adverse events (TEAEs)
Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)
Measured: Up to Day 9 (+/- 3 days)
(Part B) Incidence of treatment-emergent adverse events (TEAEs)
Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)
Measured: Up to Day 15 (+/- 3 days)
(Part A) Incidence of serious adverse events (SAEs)
Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)
Measured: Up to Day 9 (+/- 3 days)
(Part B) Incidence of serious adverse events (SAEs)
Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)
Measured: Up to Day 15 (+/- 3 days)
(Part A) Incidence of abnormal clinically significant vital signs
Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)
Measured: Up to Day 9 (+/- 3 days)
(Part B) Incidence of abnormal clinically significant vital signs
Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)
Measured: Up to Day 15 (+/- 3 days)
(Part A) Changes from baseline in liver enzymes and bilirubin
Changes from baseline in liver enzymes and bilirubin
Measured: Up to Day 9 (+/- 3 days)
(Part B) Changes from baseline in liver enzymes and bilirubin
Changes from baseline in liver enzymes and bilirubin
Measured: Up to Day 15 (+/- 3 days)
(Part A) Changes from baseline in coagulation parameters, INR and aPTT
Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)
Measured: Up to Day 9 (+/- 3 days)
(Part B) Changes from baseline in coagulation parameters, INR and aPTT
Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)
Measured: Up to Day 15 (+/- 3 days)
Secondary outcomes (18)
(Part A) Maximum plasma MNKD-201 concentration (Cmax)
(Part A) Maximum plasma MNKD-201 concentration (Cmax)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Maximum plasma MNKD-201 concentration (Cmax)
(Part B) Maximum plasma MNKD-201 concentration (Cmax)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Time to maximum concentration (Tmax)
(Part A) Time to maximum concentration (Tmax)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Time to maximum concentration (Tmax)
(Part B) Time to maximum concentration (Tmax)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Terminal elimination half-life (t½)
(Part A) Terminal elimination half-life (t½)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Terminal elimination half-life (t½)
(Part B) Terminal elimination half-life (t½)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
(Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
(Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent terminal elimination rate constant (Kel)
(Part A) Apparent terminal elimination rate constant (Kel)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent terminal elimination rate constant (Kel)
(Part B) Apparent terminal elimination rate constant (Kel)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent total body clearance (CL/F)
(Part A) Apparent total body clearance (CL/F)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent total body clearance (CL/F)
(Part B) Apparent total body clearance (CL/F)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent volume of distribution during the terminal phase (Vz/F)
(Part A) Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent volume of distribution during the terminal phase (Vz/F)
(Part B) Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing
(Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose)
Measured: predose and 5, 15, 30, 60, 90, and 120 minutes postdose
(Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing
(Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose)
Measured: predose and 5, 15, 30, 60, 90, and 120 minutes postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start28 May 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This first-in-human trial will be conducted in healthy adult volunteers and will investigate the safety, tolerability, and PK of MNKD-201. MNKD-201 will be evaluated over a range of doses, first in a SAD phase (Part A) and then in a MAD phase (Part B), to inform doses for further evaluation in a subsequent trial. Approximately 40 participants will be enrolled into 1 of 3 SAD cohorts and 2 MAD cohorts, 8 participants per cohort.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532942
- Sponsor's protocol ID
- MKC-NI-001
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fares WH, Castagna M. Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases. J Aerosol Med Pulm Drug Deliv. 2026 Aug;39(4):185-197. doi: 10.1177/19412711251414386. Epub 2026 Jan 13.
PubMed 42377397
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06532942
- Acronym / sponsor ID
- MKC-NI-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This first-in-human trial will be conducted in healthy adult volunteers and will investigate the safety, tolerability, and PK of MNKD-201. MNKD-201 will be evaluated over a range of doses, first in a SAD phase (Part A) and then in a MAD phase (Part B), to inform doses for further evaluation in a subsequent trial. Approximately 40 participants will be enrolled into 1 of 3 SAD cohorts and 2 MAD cohorts, 8 participants per cohort.
| Arm | Type | Receives |
|---|---|---|
| (Part A) MKND-201 SAD | Experimental | Drug: (Part A) MKND-201Part 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 | Drug: (Part B) MKND-201Part 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 | Drug: PlaceboAdministered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Part A) MKND-201Participants 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 | Drug | (Part A) MKND-201 SAD |
| PlaceboParticipants will receive matching placebo across Part A and Part B of the study. | Drug | Placebo |
| (Part B) MKND-201Participants 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 | Drug | (Part B) MKND-201 MAD |
Primary outcome
(Part A) Incidence of inhaled intolerability
Time frame: Up to Day 9 (+/- 3 days)
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
(Part B) Incidence of inhaled intolerability
Time frame: Up 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 postdose
Time frame: Up 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 postdose
Time frame: Up 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 measurement
Time frame: Up 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 measurement
Time frame: Up 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 signs
Time frame: Up 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 signs
Time frame: Up 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 bilirubin
Time frame: Up to Day 9 (+/- 3 days)
Changes from baseline in liver enzymes and bilirubin
(Part B) Changes from baseline in liver enzymes and bilirubin
Time frame: Up to Day 15 (+/- 3 days)
Changes from baseline in liver enzymes and bilirubin
(Part A) Changes from baseline in coagulation parameters, INR and aPTT
Time frame: Up 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 aPTT
Time frame: Up to Day 15 (+/- 3 days)
Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)
18 secondary outcomes
(Part A) Maximum plasma MNKD-201 concentration (Cmax)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Maximum plasma MNKD-201 concentration (Cmax)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Time to maximum concentration (Tmax)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Time to maximum concentration (Tmax)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Terminal elimination half-life (t½)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Terminal elimination half-life (t½)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent terminal elimination rate constant (Kel)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent terminal elimination rate constant (Kel)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent total body clearance (CL/F)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent total body clearance (CL/F)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose
(Part B) Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7
(Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing
Time frame: predose and 5, 15, 30, 60, 90, and 120 minutes postdose
(Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing
Time frame: predose and 5, 15, 30, 60, 90, and 120 minutes postdose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 42377397Fares WH, Castagna M. Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases. J Aerosol Med Pulm Drug Deliv. 2026 Aug;39(4):185-197. doi: 10.1177/19412711251414386. Epub 2026 Jan 13.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (Part A) MKND-201 and (Part B) MKND-201 in people with Healthy Volunteers, run by Mannkind Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Pleitez (818-661-5000, MKC-NI-001study@mannkindcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Part A) Incidence of inhaled intolerability (time frame: Up to Day 9 (+/- 3 days)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06532942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.