A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants

NCT02016066 | Withdrawn Phase 1

• 2 other identifiers: CR102897CR6261FLZ1003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR6261 in Japanese healthy participants

Conditions

Healthy

Keywords

Healthy; CR6261; Japanese; Safety; Pharmacokinetics; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Up to 76 days

Secondary Outcomes (4)

• Maximum observed serum CR6261 concentration

  Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day

• Time to reach the maximum observed serum CR6261 concentration

  Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day

• Area under the serum CR6261 concentration-time curve

  Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day

• Level of antibodies to CR6261 in serum samples

  Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day

Study Arms (2)

CR6261

EXPERIMENTAL

Drug: CR6261

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CR6261 DRUG

CR6261 50 mg/kg solution will be administered as a single 2-hour intravenous infusion

CR6261

Placebo DRUG

Placebo will be administered as a single 2-hour intravenous infusion

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have signed an informed consent document
• Body mass index between 18 and 30 kg/m2, with body weight greater than or equal to 50 kg at screening
• Must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm from the study drug administration until Day 76
• Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening
• Non-smoker or participant who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the study drug administration

You may not qualify if:

• History of or current clinically significant medical illness determined by the investigators including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, and coagulation disorders
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
• Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram
• A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection within 14 days before the study drug administration is scheduled
• Participants with a fever of over 37.5°C on Day -1 or at predose

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

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: December 14, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 6, 2017

Record last verified: 2016-11

Locations

JP (1)