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

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 - GSK2245035 SAD study in HV and rhinitis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36044

Enrollment

Registered

2011-05-02

Start date

2011-06-20

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Allergic reaction

Interventions

Study Medication Active substance: GSK2245035 Activity: TLR7 agonist Indication: allergic rhinitis Strength: 0.01, 0.1, 1, 10 and 100 *g/mL Dosage form: nasal spray solution Treatments Part 1 Cohor

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination Pharmacodynamics Pharmacokinetics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)