An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route

An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route - GBR 830 pharmacokinetics, absolute bioavailability and safety study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42954

Enrollment

Registered

2016-11-09

Start date

2017-01-09

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

autoimmune disease

Interventions

Healthy male and female volunteers between the age of 18-55 years, inclusive, with a BMI between 18.5 and 32.0 kg / m2, inclusive.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy volunteers 18-55 years, inclusive BMI: 18.5-32.0 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 60 days from the start of the study. In case of donating more than 0.45 liters of blood in the 3 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To determine absolute bioavailability of GBR 830 administered by the SC route in healthy adult subjects.	—

Secondary

Measure	Time frame
To evaluate the PK of GBR 830 in healthy adult subjects following single dose SC and IV administration. To evaluate the immunogenicity after single doses of GBR 830 in healthy adult subjects following SC and IV administration. To evaluate the safety and tolerability of single doses of GBR 830 in healthy adult subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)