Phase 1
Completed N=32
Single-Dose Study of MT203
Healthy Volunteers
Source: ClinicalTrials.gov NCT02354599 ↗
Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Jun 2016
Primary outcomePrimary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) — 3; 3; 1; 1 participants
Summary
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) |
3; 3; 1; 1; 1; 5 | — |
| PRIMARY Number of Participants With TEAEs Related to Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Body Weight |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Lung Functioning Monitoring |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203 |
315573.3; 575180.7; 1238496.3; 559689.3 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203 |
286383.2; 502017.5; 1106605.2; 451596.7 | — |
| SECONDARY Maximum Observed Serum Concentrations (Cmax) of MT203 |
8381.3; 15354.5; 32580.7; 10826.7 | — |
| SECONDARY Terminal Elimination Half-Life (T1/2) of MT203 |
23.75; 26.20; 26.15; 32.60 | — |
| SECONDARY Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration |
0.000; 0.000; 0.000; 0.000; 0.000; 0.000 | — |
| SECONDARY Number of Participants With Positive Response for Anti MT203 Antibody |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria: -
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorizations prior to the initiation of any study procedures.
- The participant is a healthy adult male of Japanese or Caucasian (born to Caucasian parents and grandparents).
- The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
- The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m2) (for Japanese) or between 18.5 and 30.0 kg/m2 (for Caucasian), inclusive at screening and Day-1.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks (126 days) after last dose.
Exclusion Criteria: -
- The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study medication.
- The participant has received MT203 or other anti-granulocyte-macrophage colony stimulating factor (GM-CSF) drugs in a previous clinical study.
- The participant has been vaccinated within 4 weeks (28 days) prior to the first dose of study medication or is scheduled to be vaccinated during the study.
- The participant is an immediate family member, study site employee or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormalities, which may impact the ability of the participant to participate or potentially confound the study results.
- History of frequent or chronic infections or herpes zoster.
- The participant has a history of or currently has significant pulmonary disease, inflammatory disease or autoimmune disease.
- The participant has a known hypersensitivity to any component of the formulation of MT203.
- The participant has a positive urine drug result for drugs of abuse at screening. 10. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- The participant has taken or requires excluded medications, supplements or food products listed in the Excluded Medications section throughout the study.
- The participant intends to donate sperm during the course of this study or for 18 weeks after the last dose of study medication.
- The participant has a history of cancer. 14. Presence, suspicion or history of active tuberculosis (TB) or latent TB infection.
- The participant has a positive test result for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis B virus antibody (HBV surface virus antibody [HBsAb]/ HBV core antibody [HBcAb]), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening. However, participants who are positive for HBsAb due to HBV vaccination are exempt.
- The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 4 weeks (28 days) prior to the first dose of study medication.
- The participant has clinically relevant decreased lung function, example, forced expiratory volume in the first second (FEV1) less than ( ) 1.5 times the upper limit of normal or neutrophil counts and/or monocyte counts < the lower limit of normal.
- Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for the study with any other reason.
Data sourced from ClinicalTrials.gov (NCT02354599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.