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

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 - MMI-0100 MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43064

Enrollment

Registered

2016-02-11

Start date

2016-03-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathische Fibrose Idiopathic pulmoary fibrosis pulmonary diseases

Interventions

Group 1: multiple pulmonary doses of 5.0 mg MMI-0100 (n=6) or matching placebo (n=2) once daily for 7 days Group 2: multiple pulmonary doses of 10.0 mg MMI-0100 (n=6) or matching placebo (n=2) once

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To characterize the systemic pharmacokinetics (PK) of MMI-0100 by inhaled delivery	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)