A Clinical Study to Investigate How Safe and Tolerable th... | NCT03156738

NCT03156738

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose 1	Experimental	MT-2990 or Placebo	Drug: MT-2990 Drug: Placebo
Dose 2	Experimental	MT-2990 or Placebo	Drug: MT-2990 Drug: Placebo
Dose 3	Experimental	MT-2990 or Placebo	Drug: MT-2990 Drug: Placebo
Dose 4	Experimental	MT-2990 or Placebo	Drug: MT-2990 Drug: Placebo
Dose 5	Experimental	MT-2990 or Placebo	Drug: MT-2990 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MT-2990	Drug	Subjects will receive a single IV dose of MT-2990	Dose 1 Dose 2 Dose 3 Dose 4 Dose 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability as measured by incidence, nature and severity of adverse events	Adverse events will be summarised by dose level.	Up to Day 85
Safety and tolerability as measured by vital signs	Vital signs variables and changes from Baseline will be summarised by dose level.	Up to Day 85
Safety and tolerability as measured by ECG parameters	12-lead ECG variables and changes from Baseline will be summarised by dose level.	Up to Day 85
Safety and tolerability as measured by clinical laboratory assessments	Laboratory variables and changes from Baseline will be summarised by dose level.	Up to Day 85
Safety and tolerability as measured by physical examination	Physical examination data will be listed by subject.	Up to Day 85

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed serum concentration (Cmax) of MT-2990	Cmax will be summarised by dose level.	Up to Day 85
Measured time of maximum observed serum concentration (tmax) of MT-2990	tmax will be summarised by dose level.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects are able and willing to provide written informed consent to participate in this study
Healthy male subjects aged 18 to 55 years (inclusive)
Free from clinically significant (CS) illness or disease
Body weight of 60 to 100 kg (inclusive)
Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).

Exclusion Criteria:

A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression)
Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1
A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months)
A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
An active, or history of, parasitic infections; any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (e.g., history of splenectomy)
Presence or history of severe adverse reaction or allergy to any drug or allergy that is of clinical significance to the Investigational Medicinal Product (IMP)
A positive test result for QuantiFERON-TB Gold® Plus, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.