A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2) - GBR 830 SAD and PD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41093

Enrollment

Registered

2014-07-10

Start date

2014-09-11

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

autoimmune disease

Interventions

Part 1: During the study the volunteer will receive GBR 830 or placebo by an intravenous infusion of 1 hour, approximately 1 hour after completing a light breakfast. Part 2: On Day 1 of the study t

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 90 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
Part 1: To evaluate the safety and tolerability of single ascending doses of GBR 830 in adult healthy volunteers. Part 2: To evaluate the effect of a single dose of GBR 830 in adult, healthy volunteers on -T-cell dependent primary (naïve) antibody response to neo-antigen KLH and -T-cell dependent recall/memory antibody response to Tetanus toxoid (TT) antigen.	—

Secondary

Measure	Time frame
Part 1: To evaluate the PK and immunogenicity of single ascending doses of GBR 830 in adult healthy volunteers. Part 2: -To evaluate the effect of single dose of GBR 830 on DTH to intra dermal (i.d) administration of Candida in adult, healthy volunteers. -To evaluate the safety, tolerability, PK and immunogenicity of single dose of GBR 830 in adult, healthy volunteers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)