A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
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Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
40estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-28 | actual | When the study began enrolling |
| Primary completion | 2024-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2024-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: (Part A) MKND-201
- Drug: Placebo
- Drug: (Part B) MKND-201
Primary outcomes
what the primary-completion date above is the date OF(Part A) Incidence of inhaled intolerability
measured Up to Day 9 (+/- 3 days)
(Part B) Incidence of inhaled intolerability
measured Up to Day 15 (+/- 3 days)
(Part A) 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
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
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
measured Up to Day 15 (+/- 3 days)
(Part A) Incidence of treatment-emergent adverse events (TEAEs)
measured Up to Day 9 (+/- 3 days)
(Part B) Incidence of treatment-emergent adverse events (TEAEs)
measured Up to Day 15 (+/- 3 days)
(Part A) Incidence of serious adverse events (SAEs)
measured Up to Day 9 (+/- 3 days)
(Part B) Incidence of serious adverse events (SAEs)
measured Up to Day 15 (+/- 3 days)
(Part A) Incidence of abnormal clinically significant vital signs
measured Up to Day 9 (+/- 3 days)
(Part B) Incidence of abnormal clinically significant vital signs
measured Up to Day 15 (+/- 3 days)
(Part A) 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
measured Up to Day 15 (+/- 3 days)
(Part A) Changes from baseline in coagulation parameters, INR and aPTT
measured Up to Day 9 (+/- 3 days)
(Part B) Changes from baseline in coagulation parameters, INR and aPTT
measured Up to Day 15 (+/- 3 days)
Publications
- PMID 42377397 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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