A randomized, open-label, two-period, two-sequence, single-dose, cross-over study to compare the pharmacokinetics, safety, and tolerability of the auto injector and pre-filled syringe of SB4 in healthy male subjects.

A randomized, open-label, two-period, two-sequence, single-dose, cross-over study to compare the pharmacokinetics, safety, and tolerability of the auto injector and pre-filled syringe of SB4 in healthy male subjects. - Study comparing PK of SB4 between auto injector and pre-filled syringe.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45442

Enrollment

Registered

2017-02-15

Start date

2017-04-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Auto immune diseases

Interventions

Not applicable.

Autoimmune diseases

Psoriasis

Rheumatoid arthritis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years of age, inclusive BMI 20.0 - 28.0 kg/m2, inclusive weight 60.0 - 85.5 kilograms, inclusive non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
The primary objective is to demonstrate bioequivalence of the pharmacokinetic (PK) profiles between SB4 Autoinjector (AI) and SB4 Pre-filled syringe (PFS) based on AUCinf, AUClast and Cmax in healthy male subjects.	—

Secondary

Measure	Time frame
The secondary objective is to investigate the safety and tolerability between SB4 AI and SB4 PFS in healthy male subjects.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)