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)

Completed

Conditions: 10003816
autoimmune disease

Registration Number: NL-OMON41093

Lead Sponsor: Glenmark Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

healthy volunteers
18-55 years, inclusive
BMI: 18.5-32.0 kg/m2, inclusive

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>To evaluate the PK and immunogenicity of single ascending doses of GBR 830 in<br /><br>adult healthy volunteers.<br /><br><br /><br>Part 2:<br /><br>-To evaluate the effect of single dose of GBR 830 on DTH to intra dermal (i.d)<br /><br>administration of Candida in adult, healthy volunteers.<br /><br>-To evaluate the safety, tolerability, PK and immunogenicity of single dose of<br /><br>GBR 830 in adult, healthy volunteers.</p><br>