drugset / Trial / NCT02593331

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance

NCT02593331 ↗

Phase 1 Completed 79 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index \[BMI\] greater than \[\>\] 27 to less than or equal to \[\</=\] 40 kilograms per square meter \[kg/m\^2\]) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will open to evaluate the PK of BFKB8488A after intravenous (IV) administration.

Timeline

Start
2015-10-29
Primary completion
2017-03-28
Completion
2017-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject FAZPILODEMAB Monoclonal antibody — Subcutaneous

Indications

No indication recorded.