A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- Drug: MT-2990Drug: Placebo
- Registration Number
- NCT03156738
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 4 MT-2990 MT-2990 or Placebo Dose 4 Placebo MT-2990 or Placebo Dose 2 MT-2990 MT-2990 or Placebo Dose 1 MT-2990 MT-2990 or Placebo Dose 5 MT-2990 MT-2990 or Placebo Dose 5 Placebo MT-2990 or Placebo Dose 1 Placebo MT-2990 or Placebo Dose 3 MT-2990 MT-2990 or Placebo Dose 2 Placebo MT-2990 or Placebo Dose 3 Placebo MT-2990 or Placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability as measured by ECG parameters Up to Day 85 12-lead ECG variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by physical examination Up to Day 85 Physical examination data will be listed by subject.
Safety and tolerability as measured by incidence, nature and severity of adverse events Up to Day 85 Adverse events will be summarised by dose level.
Safety and tolerability as measured by clinical laboratory assessments Up to Day 85 Laboratory variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by vital signs Up to Day 85 Vital signs variables and changes from Baseline will be summarised by dose level.
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) of MT-2990 Up to Day 85 Cmax will be summarised by dose level.
Apparent terminal elimination half-life (t1/2) of MT-2990 Up to Day 85 t½ will be summarised by dose level.
Terminal elimination rate constant (Kel) of MT-2990 Up to Day 85 Kel will be summarised by dose level.
Apparent volume of distribution at steady state (Vss) of MT-2990 Up to Day 85 Vss will be summarised by dose level.
Measured time of maximum observed serum concentration (tmax) of MT-2990 Up to Day 85 tmax will be summarised by dose level.
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990 Up to Day 85 AUC0-last will be summarised by dose level.
AUC from time zero to infinity (AUC0-∞) of MT-2990 Up to Day 85 AUC0-∞ will be summarised by dose level.
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990 Up to Day 85 MRT0-∞ will be summarised by dose level.
Proportion of subjects who develop antibodies against MT-2990 in serum Up to Day 85 The proportion of subjects who develop antibodies against MT 2990 in serum will be summarised using descriptive statistics on the Safety Analysis Set.
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990 Up to Day 85 Vz will be summarised by dose level.
Apparent serum clearance (CL) of MT-2990 Up to Day 85 CL will be summarised by dose level.
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990 Up to Day 85 %AUCex will be summarised by dose level.
Trial Locations
- Locations (1)
Pharmaceutical Research Associates (PRA) Health Sciences
🇳🇱NZ Groningen, Netherlands