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drugset / Trial / NCT01299298

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers

NCT01299298 ↗

Phase 1 Completed 20 enrolled Kastle Therapeutics, LLC Ionis Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will receive a single study injection of either mipomersen or placebo. Subjects will be enrolled into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design. Dose-escalation will proceed only if there is an acceptable safety profile from the previous dosing level.

Timeline

Start
2011-01
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject mipomersen Antisense oligonucleotide 50 mg Subcutaneous
Subject mipomersen Antisense oligonucleotide 100 mg Subcutaneous
Subject mipomersen Antisense oligonucleotide 200 mg Subcutaneous

Indications

No indication recorded.