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Clinical Trials, and HPO
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There is one clinical trial.
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.
Description: AEs and SAEs will be collected.
Measure: Part A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: Up to 141 daysDescription: Number of participants with abnormal hematology, chemistry, urinalysis parameters, ECG findings, and vital signs will be analyzed.
Measure: Part A and B: Number of participants with abnormal hematology, chemistry, urinalysis parameters, electrocardiogram (ECG) findings, and vital signs Time: Up to 141 daysDescription: Change from Baseline in knee pain due to OA will be assessed by average of daily pain NRS at Week 8. The pain NRS is an 11-point scale (0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 represents the worst possible pain.
Measure: Part B: Change from Baseline in knee pain as assessed by average of daily pain numeric rating scale (NRS) at Week 8 Time: Baseline and Week 8Description: Change from Baseline in worst knee pain intensity will be assessed using NRS at Week 8. The pain NRS is an 11-point scale (0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 represents the worst possible pain.
Measure: Part B: Change from Baseline in worst knee pain intensity as assessed by NRS at Week 8 Time: Baseline and Week 8Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Serum concentrations of GSK3858279 following a single IV dose Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Serum concentration of GSK3858279 following single SC dose Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: Serum concentration of GSK3858279 following repeat SC dose Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: AUC from zero to time t (0-t) (AUC[0-t]) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: AUC from zero to infinity (0-infinity) (AUC[0-infinity]) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: AUC(0-tau) following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: AUC(0-t) following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: AUC(0-infinity) following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: AUC(0-tau) following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: AUC(0-t) following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: AUC(0-infinity) following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Maximum concentration (Cmax) after a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Cmax after single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: Cmax after repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Half-life (t1/2) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: t1/2 following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: t1/2 following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Clearance (CL) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: CL following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: CL following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Volume of distribution at steady state (Vss) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Vss following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: Vss following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points
Measure: Part A: Volume of distribution (V) following a single IV dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part A: Volume of distribution (V) following a single SC dose of GSK3858279 Time: Up to 141 daysDescription: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.
Measure: Part B: Volume of distribution (V) following a repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.
Measure: Part A: Free Chemokine ligand 17 (CCL17) levels in serum following single IV dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.
Measure: Part A: Free CCL17 levels in serum following single SC dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.
Measure: Part B: Free CCL17 levels in serum following repeat SC dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.
Measure: Part A: Total CCL17 levels in serum following single IV dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.
Measure: Part A: Total CCL17 levels in serum following single SC dose of GSK3858279 Time: Up to 141 daysDescription: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.
Measure: Part B: Total CCL17 levels in serum following repeat SC dose of GSK3858279 Time: Up to 141 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports