BE study of tocilizumab

AN OPEN LABEL, RANDOMIZED, SINGLE CENTER, TWO-STAGE, TWO-PERIOD CROSS-OVER STUDY TO INVESTIGATE THE BIOEQUIVALENCE OF TOCILIZUMAB IN HEALTHY SUBJECTS FOLLOWING SUBCUTANEOUS ADMINISTRATION OF CURRENT COMMERCIAL PRODUCT AND NEW PRODUCT

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223096

Enrollment

Registered

2016-02-04

Start date

2016-02-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

healthy volunteers

Interventions

investigational material(s) Generic name etc : Tocilizumab INN of investigational material : Tocilizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male or female subject, 20 to 44 years of age, inclusive. Health status is confirmed by absence of evidence of any active or chronic disease.

Exclusion criteria

Exclusion criteria: Subject who is HBs antigens positive, HBs/HBc antibodies positive, HCV antibodies positive, HIV antigen/antibody positive, syphilis or TB (Chest X-ray and PPD or IFN-gamma release assay) at the screening. Have taken TCZ in the past.

Design outcomes

Primary

Measure	Time frame
bioequivalence To evaluate the bioequivalence (BE) of tocilizumab (TCZ) following single dose of 162 mg subcutaneous (SC) administration of drug product derived from drug substance manufactured using the current commercial product and the new product process. Laboratory tests	—

Secondary

Measure	Time frame
safety pharmacokinetics To evaluate the safety and tolerability following single dose of 162 mg TCZ SC administered as product derived from drug substance manufactured using the current commercial product and the new product process. To assess immunogenicity following single dose of 162 mg TCZ SC administered as product derived from drug substance manufactured using the current commercial product and the new product process. Observation, laboratory tests	—

Measure

Time frame

safety pharmacokinetics To evaluate the safety and tolerability following single dose of 162 mg TCZ SC administered as product derived from drug substance manufactured using the current commercial product and the new product process. To assess immunogenicity following single dose of 162 mg TCZ SC administered as product derived from drug substance manufactured using the current commercial product and the new product process. Observation, laboratory tests

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026