Phase 1 Single Subcutaneous Dose Study of MLN1202

NCT02426021 | Withdrawn Phase 1

• 3 other identifiers: MLN1202/CPH-001U1111-1169-0038JapicCTI-152874
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.

Conditions

Healthy Japanese and Caucasian Male Adults

Outcome Measures

Primary Outcomes (1)

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

  The adverse event is defined as any unfavorable and unintended sign, symptom, or disease that develops when a drug is administered, irrespective of the causal relationship to the drug.

  Up to Day 37

Secondary Outcomes (4)

• Maximum observed serum concentration (Cmax) of MLN1202

  Up to Day 37

• Area under the serum concentration-time curve (AUC) of MLN1202 in serum

  Up to Day 37

• Changes in serum monocyte chemoattractant protein-1 (MCP-1) concentrations

  Up to Day 37

• Changes in monocyte count from baseline

  Up to Day 37

Study Arms (10)

Cohort J1: MLN1202 (75 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (75 mg) in 6 healthy Japanese male adults

Drug: MLN1202

Cohort J1: placebo

EXPERIMENTAL

Single subcutaneous administration of placebo in 2 healthy Japanese male adults

Drug: MLN1202 Placebo

Cohort J2:MLN1202 (105 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (105 mg) in 6 healthy Japanese male adults

Drug: MLN1202

Cohort J2: placebo

EXPERIMENTAL

Single subcutaneous administration of placebo in 2 healthy Japanese male adults

Drug: MLN1202 Placebo

Cohort J3: MLN1202 (150 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (150 mg) in 6 healthy Japanese male adults

Drug: MLN1202

Cohort J3: placebo

EXPERIMENTAL

Single subcutaneous administration of placebo in 2 healthy Japanese male adults

Drug: MLN1202 Placebo

Cohort J4: MLN1202 (450 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (450 mg) in 6 healthy Japanese male adults

Drug: MLN1202

Cohort J4: placebo

EXPERIMENTAL

Single subcutaneous administration of placebo in 2 healthy Japanese male adults

Drug: MLN1202 Placebo

Cohort C1: MLN1202 (75 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (75 mg) in healthy Causacian male adults

Drug: MLN1202

Cohort C2: MLN1202 (150 mg)

EXPERIMENTAL

Single subcutaneous administration of MLN1202 (150 mg) in healthy Causacian male adults

Drug: MLN1202

Interventions

MLN1202 DRUG

Subcutaneous administration of MLN1202

Cohort C1: MLN1202 (75 mg); Cohort C2: MLN1202 (150 mg); Cohort J1: MLN1202 (75 mg); Cohort J2:MLN1202 (105 mg); Cohort J3: MLN1202 (150 mg); Cohort J4: MLN1202 (450 mg)

MLN1202 Placebo DRUG

Subcutaneous administration of MLN1202 placebo

Cohort J1: placebo; Cohort J2: placebo; Cohort J3: placebo; Cohort J4: 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 (ICF) prior to the initiation of any study procedures.
• The participant is a healthy adult man who is defined as Japanese (all parents and grandparents of the participant are Japanese) or Caucasian (all parents and grandparents of the participant are Caucasian).
• The participant is between 20 and 45 years of age at the time of informed consent.
• The participant has a body weight of at least 50 kg and has a body mass index (BMI) between 18.5 and 25.0 kg /m2 when the participant is Japanese or between 18.5 and 30.0 kg /m2 when the participant is Caucasian at the time of screening and baseline examination.
• A male participant who is sexually active with a female partner of childbearing potential and who has not received contraceptive therapy agrees to use adequate contraception from the time of informed consent until 12 weeks (84 days) after administration of the study drug.

You may not qualify if:

• The participant has received any other investigational compound within 16 weeks (112 days) prior to administration of the study drug.
• The participant has previously received agents containing MLN1202, a monoclonal antibody or monoclonal antibody fragment.
• The participant has been vaccinated within 4 weeks (28 days) prior to administration of the study drug or is planning to be vaccinated during the study period.
• The participant is a study site employee or immediate family member of the employee, or may consent under duress.
• The participant has poorly-controlled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease, hemorrhagic disorder or other abnormalities which may impact the ability of the participant to participate or potentially confound the study results.
• The participant has recurrent serious or poorly-controlled infection and is considered to have difficulty participating in the study by the investigator.
• The participant has a history of hypersensitivity or allergies to MLN1202 or additives contained in MLN1202 preparations.
• The participant has a history of hypersensitivity or allergies to monoclonal antibodies other than MLN1202.
• The participant has positive results in urine drug tests at screening.
• The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence within 2 years prior to the study visit at screening or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
• The participant requires any excluded medication or food products listed in the Excluded Medications and Dietary Products (see section 7.3) during the study period.
• The participant intends to donate sperm during the study period or period until 12 weeks (84 days) after administration of the study drug.
• The participant has a history of cancer.
• The participant has, is suspected of having, or has a history of active tuberculosis or latent tuberculosis infection.
• The participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis B virus antibody (hepatitis B surface antibody \[HBsAb\]/ hepatitis B core antibody \[HBcAb\]), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening. This does not include the participant who has a positive test result only for HBsAb due to HBV vaccination.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

plozalizumab

Study Officials

• Medical Director

  Takeda

  STUDY CHAIR

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: April 21, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

JP (1)