An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects - UCB4940 sc absolute BA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41792

Enrollment

Registered

2014-11-05

Start date

2014-11-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

psoriasis rheumatoid arthritis

Interventions

The study will consist of 1 period during which the volunteer will receive UCB4940 once. UCB4940 will be given in the form of a sc injection or an iv infusion. Please refer to the table below to s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy subjects 40-65 years, inclusive BMI: 19.0-28.0 kg/m2, inclusive

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 90 days from the start of the study. In case of donating more than 0.4 liters of blood in the 90 days prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To determine the Abs BA of single sc doses of UCB4940, 80mg and 160mg, in healthy subjects	—

Secondary

Measure	Time frame
- To evaluate the dose proportionality of UCB4940 pharmacokinetics (PK) when given as 80mg or 160mg sc. - To evaluate the safety and tolerability of UCB4940 when given as 80mg sc or 160mg sc or 160mg iv	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)