A randomized, double-blind, placebo-controlled first time into human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of intranasal dosing with GSK2245035, a TLR7 agonist, in healthy volunteers and allergic rhinitics

Completed

• Conditions: Allergic reaction; hay fever; 10024970

• Registration Number: NL-OMON36044
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Part 1:
healthy male volunteers
18 - 55 years of age
BMI 19 - 29.9 kg/m2;Part 2:
male volunteers with a pollen allergy
18 - 55 years of age
BMI 19 - 29.9 kg/m2
positive RAST test for pollen allergy

Exclusion Criteria

- Suffering from: hepatitis B, cancer or HIV/AIDS
- Participation in another drug study within 3 months prior to dosing in this study
- Blood donation within 3 months prior to dosing in this study of donated more than 1.5 liters of blood in the 10 months prior to dosing in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination<br /><br>Pharmacodynamics<br /><br>Pharmacokinetics</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>