Single-Dose Study of MT203

NCT02354599 | Completed Phase 1 Results

• 3 other identifiers: MT203/CPH-001U1111-1163-4003JapicCTI-142699
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study

Outcome Measures

Primary Outcomes (6)

• Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

  Baseline up to Day 85

• Number of Participants With TEAEs Related to Vital Signs

  Baseline up to Day 85

• Number of Participants With TEAEs Related to Body Weight

  Baseline up to Day 85

• Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)

  Baseline up to Day 85

• Number of Participants With TEAEs Related to Lung Functioning Monitoring

  Baseline up to Day 85

• Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis

  Baseline up to Day 85

Secondary Outcomes (6)

• Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203

  Predose and at multiple time points (up to 84 days) post-dose

• Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203

  Predose and at multiple time points (up to 84 days) post-dose

• Maximum Observed Serum Concentrations (Cmax) of MT203

  Predose and at multiple time points (up to Day 84) post-dose

• Terminal Elimination Half-Life (T1/2) of MT203

  Predose and at multiple time points (up to 84 days) post-dose

• Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration

  Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84

Study Arms (8)

Cohort 1: MT203 80 mg

EXPERIMENTAL

Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 80 mg or matching Placebo

Cohort 1: MT203 80 mg matching placebo

PLACEBO COMPARATOR

Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 80 mg or matching Placebo

Cohort 2: MT203 150 mg

EXPERIMENTAL

Six Japanese participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 150mg or matching Placebo

Cohort 2: MT203 150 mg matching placebo

PLACEBO COMPARATOR

Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 150mg or matching Placebo

Cohort 3: MT203 300 mg

EXPERIMENTAL

Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 300 mg or matching placebo

Cohort 3: MT203 300 mg matching placebo

PLACEBO COMPARATOR

Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 300 mg or matching placebo

Cohort 4: MT203 150 mg

EXPERIMENTAL

Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously.

Drug: MT203 150mg or matching Placebo

Cohort 4: MT203 150 mg matching placebo

PLACEBO COMPARATOR

Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously

Drug: MT203 150mg or matching Placebo

Interventions

MT203 80 mg or matching Placebo DRUG

MT203 80 mg or matching placebo injection

Also known as: Namilumab, Placebo

Cohort 1: MT203 80 mg; Cohort 1: MT203 80 mg matching placebo

MT203 150mg or matching Placebo DRUG

MT203 150mg or matching placebo injection

Also known as: Namilumab, Placebo

Cohort 2: MT203 150 mg; Cohort 2: MT203 150 mg matching placebo; Cohort 4: MT203 150 mg; Cohort 4: MT203 150 mg matching placebo

MT203 300 mg or matching placebo DRUG

MT203 300 mg or matching placebo injection

Also known as: Namilumab, Placebo

Cohort 3: MT203 300 mg; Cohort 3: MT203 300 mg matching placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 (\<) 70 percent (%) of the predicted value.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Related Publications (1)

• Tanaka S, Harada S, Hiramatsu N, Nakaya R, Kawamura M. Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men . Int J Clin Pharmacol Ther. 2018 Nov;56(11):507-517. doi: 10.5414/CP203235.

  PMID: 30168415 DERIVED

MeSH Terms

Interventions

namilumab

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Senior Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: February 3, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 20, 2016
• Results First Posted: June 20, 2016

Record last verified: 2016-05

Locations

JP (1)