A Randomised Double Blind (Sponsor Unblinded), Single and Repeat Ascending Dose First Time in Human Study in Healthy Subjects, Cold Urticaria and Chronic Spontaneous Urticaria Subjects to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

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GlaxoSmithKline

Description

This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding placebo within the same subject, in healthy adult subjects (Part A), subjects with cold urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The study will also measure short term effects of GSK2646264 on the number and size of weals in subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.

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Mentions (0)

Metrics

Dataset Index

0.8

FAIR Score

31%

Citations

0

Mentions

0

Metrics Over Time

Publication Details

DOI

Publisher

Vivli

Assigned Domain

Subfield

Rheumatology

Field

Medicine

Domain

Health Sciences

Confidence Score

41%

Source

Scholar Data Model

Keywords

Conditions: UrticariaInterventions: GSK2646264 0.5% topical creamInterventions: GSK2646264 1% topical creamInterventions: Placebo

Normalization Factors

FT

13.46

CTw

1.00

MTw

1.00