SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02318407

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain

This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).

NCT02318407 Osteoarthritis
MeSH: Osteoarthritis Osteoarthritis, Knee
HPO: Knee osteoarthritis Osteoarthritis

2 Interventions

Name: AMG 403

Description: AMG 403 for the treatment of subjects with osteoarthritis

Type: Drug

AMG 403

Name: Placebo

Description: contains no active drug

Type: Drug

Placebo


Primary Outcomes

Description: Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs

Measure: Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs

Time: from 197 days to 211 days

Secondary Outcomes

Description: serum concentrations and derived PK parameters of AMG 403

Measure: Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

Time: from 197 days to 211 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q28D

In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4). --- Q28D ---



HPO Nodes


HPO:
Knee osteoarthritis
Genes 3
COL2A1 COL9A2 SMAD3
Osteoarthritis
Genes 52
COL2A1 COL3A1 GHR PHEX TGFB3 CCN6 GDF5 COL5A1 HGD COL5A2 COL9A1 COL9A2 COL9A3 COL11A1 COL11A2 FBN1 ATP7B ZMPSTE24 UFSP2 COMP LMNA CLCN7 AEBP1 CANT1 LMX1B SLC26A2 ACAN HPGD MATN3 SCARB2 TRPS1 GBA TRPV4 EXT1 EXT2 FGFR3 AIP GNAS GPR101 MMP13 ANKH TNXB F8 SLC40A1 F9 MEFV ZNF687 SMAD3 KIF22 KIF7 COL1A1 TRAPPC2