drugset / Trial / NCT02593331
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FAZPILODEMAB | Monoclonal antibody | — | Subcutaneous |
Indications
No indication recorded.