A PHASE 1, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN HEALTHY VOLUNTEERS TO DETERMINE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ESCALATING MULTIPLE DOSES OF MMI-0100 OR PLACEBO ADMINISTERED BY PULMONARY DELIVERY

Completed

• Conditions: Idiopathische Fibrose; Idiopathic pulmoary fibrosis; pulmonary diseases

• Registration Number: NL-OMON43064
• 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: 32

Inclusion Criteria

healthy male or female
Age: between 18 and 55 years of age, inclusive
BMI: between 19.0 and 30.0 kilograms/meter2
Body weight: between 50.0 and 100.0 kg, inclusive

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 the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the safety and tolerability of pulmonary administered MMI-0100<br /><br>with daily doses for 7 days, as assessed by adverse events (AE), vital signs,<br /><br>physical exam, clinical laboratory safety assessments, pulmonary function tests<br /><br>and 12-lead electrocardiogram (ECG) parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To characterize the systemic pharmacokinetics (PK) of MMI-0100 by inhaled<br /><br>delivery</p><br>