A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213315
• Other study ID #: D2190C00016
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: January 8, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.

Description:

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject is of Japanese ethnicity

• No evidence of clinically significant respiratory disease

Exclusion Criteria:

• Any condition that, would interfere with the evaluation of the study drug or safety of subjects.

• Subject has a known hypersensitivity to any components of the investigational product.

• History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.

• Subject has a history or present condition of malignancy.

• Subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week.

• Any blood donation or significant loss of blood within 56 days of study initiation,

• Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 100mg Mavrilimumab
100mg Mavrilimumab
• 150mg mavrilimumab
150mg mavrilmumab

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile of mavrilimumab	•Non-compartmental PK parameters following a single-dose of mavrilimumab to analyse •Maximum observed concentration (Cmax); area under the concentration-time curve (AUC); time to maximum concentration (Tmax) and half-life (t1/2) from dosing to Day 85 •The number and percentage of subjects that are ADA positive will be summarized by dose	from dosing to day 85	Yes
Secondary	To evaluate the safety of mavrilimumab	•The secondary outcome of the study is the safety of mavrilimumab as measured by the frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) from dosing to day 85	from dosing to day 85	Yes