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Report for Clinical Trial NCT02318407

Developed by Shray Alag, 2020.
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 4
COL2A1 SMAD3 COL9A2 SMAD3
Osteoarthritis
Genes 85
COL5A2 UFSP2 GNAS COL9A1 MATN3 F8 COMP COL1A1 CANT1 TRPV4 MATN3 MMP13 ZNF687 FRZB CLCN7 COL2A1 COL9A2 SCARB2 MMP13 GHR LMNA COL11A2 LMX1B UFSP2 COL9A3 COL11A2 SLC40A1 GPR101 COL2A1 ACAN TGFB3 SLC26A2 COL11A1 MEFV PHEX COL9A2 TRAPPC2 COL2A1 ZMPSTE24 TRPS1 COL2A1 COL5A1 COMP COL11A2 PHEX AEBP1 COL2A1 CLCN7 COL2A1 ANKH KIF7 EXT2 COL9A3 COL2A1 HGD CCN6 AIP KIF22 ANKH ACAN FBN1 GBA HPGD CCN6 GDF5 ATP7B COL2A1 FGFR3 COMP HLA-B MATN3 TRAPPC2 COL5A1 EXT1 ACAN F9 ASPN COL3A1 COMP COL9A1 SMAD3 COL2A1 TRPV4 COL1A1 SMAD3