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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02213315

Enrollment

Registered

2014-08-11

Start date

2014-07-31

Completion date

2014-12-31

Last updated

2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, Rheumatoid Arthritis, mavrilimumab

Brief 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.

Detailed 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.

Interventions

DRUG100mg Mavrilimumab

100mg Mavrilimumab

DRUG150mg mavrilimumab

150mg mavrilmumab

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
PK profile of mavrilimumab	from dosing to day 85	•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

Secondary

Measure	Time frame	Description
To evaluate the safety of mavrilimumab	from dosing to day 85	•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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026