The purpose of the study is to investigate to what extent MMI-0100 is tolerated after multiple administrations.It will also be investigated how quickly and to what extent MMI-0100 is absorbed and eliminated from the body (this is called…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Idiopathische Fibrose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
To characterize the systemic pharmacokinetics (PK) of MMI-0100 by inhaled
delivery
Background summary
MMI-0100 is a new investigational compound that may eventually be used for the
treatment of idiopathic pulmonary fibrosis and other fibrotic and inflammatory
indications. Fibrosis is associated with an increase of fibrous tissue in
organs. This inflammatory pulmonary disease is affected by a cascade reaction
which synthesize and release of pro-inflammatory cytokines (a cytokine is a
small protein involved in the most defense mechanisms associated with
infections). MMI-0100 inhibits a part of this cascade reaction and therefore
may inhibit the inflammation process in the lungs. MMI-0100 is in development
and is not registered as a drug but has been given to humans before.
Study objective
The purpose of the study is to investigate to what extent MMI-0100 is tolerated
after multiple administrations.
It will also be investigated how quickly and to what extent MMI-0100 is
absorbed and eliminated from the body (this is called pharmacokinetics). In
addition, the effect of MMI-0100 on the lung function will be investigated
(this is called safety).
Study design
The study will consist of 1 period during which the subject will receive
MMI-0100 or placebo once daily for 7 days. MMI-0100 and placebo will be given
as in the form of an inhalation.
Intervention
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 daily for 7 days
Group 3: multiple pulmonary doses of 20.0 mg MMI-0100 (n=6) or matching placebo
(n=2) once daily for 7 days
Group 4*: multiple pulmonary doses of 40.0 mg MMI-0100 (n=6) or matching
placebo (n=2) once daily for 7 days
* Based on the results obtained from Group 1, 2 and 3, it may be decided to
decrease the 40 mg dose level in Group 4.
Study burden and risks
All potential drugs cause adverse effects; the extent to which this occurs
differs. MMI-0100 has been given to humans in 2 studies to date. In a single
dose study the most frequently observed adverse effect was cough but this may
well be associated to the method of administration as cough was reported more
often by volunteers receiving placebo then by volunteers receiving active
medication. MMI-0100 was well tolerated in man and there were no adverse
effects reported more than once.
MMI-0100 was well tolerated when given via inhalation in animals. Most adverse
events were only observed after direct injection in the body cavity. The most
frequent adverse effects were: hypotension (low blood pressure) and vascular
inflammation.
55 Madison Ave Suite 400
Morristown NJ 07960
US
55 Madison Ave Suite 400
Morristown NJ 07960
US
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005595-17-NL |
| CCMO | NL56730.056.16 |