idiopathische fibrose Idiopathic pulmonary fibrosis pulmonary diseases.
Conditions
Interventions
The study will consist of 1 period(s) during which the volunteer will receive
MMI-0100 once or placebo once. MMI-0100 and placebo will be given in the form
of an inhalation.
Sponsors
Moerae Matrix, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male or female 18 and 55 years of age, inclusive BMI 19.0 and 30.0 kilograms/meter2 Non smokers
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: Plasma MMI-0100 drug concentrations. PK parameters, including area under the concentration-time curve (AUC), maximum plasma concentration (Cmax), time to attain maximum plasma concentration (Tmax), and elimination half life (t1/2) will be determined, if possible. Comparisons across dose levels will be made to assess proportionality. Safety: AEs, vital signs, 12-lead ECG, clinical laboratory, physical examination, pulmonary function tests. Pulmonary function tests comprise forced (expiratory) vital capacity (FVC), forced expiratory volume over one second (FEV1) and vital capacity (VC). In addition TLC and DLCO will be done. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed