A study to evaluate the pharmacokinetics, safety and tolerability after inhalation of MMI-0100 in healthy subjects; MMI-0100 is an investigational drug developed for the treatment of fibrotic indications.

Completed

• Conditions: idiopathische fibrose; Idiopathic pulmonary fibrosis; pulmonary diseases.

• Registration Number: NL-OMON40896
• Lead Sponsor: Moerae Matrix, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK:<br /><br>Plasma MMI-0100 drug concentrations. PK parameters, including area under the<br /><br>concentration-time curve (AUC), maximum plasma concentration (Cmax), time to<br /><br>attain maximum plasma concentration (Tmax), and elimination half life (t1/2)<br /><br>will be determined, if possible. Comparisons across dose levels will be made to<br /><br>assess proportionality.<br /><br><br /><br>Safety:<br /><br>AEs, vital signs, 12-lead ECG, clinical laboratory, physical examination,<br /><br>pulmonary function tests. Pulmonary function tests comprise forced (expiratory)<br /><br>vital capacity (FVC), forced expiratory volume over one second (FEV1) and vital<br /><br>capacity (VC). In addition TLC and DLCO will be done. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>