NCT02193360

Pilot Study of FFP104 Dose Escalation in PBC Subjects

A Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed With Primary Biliary Cirrhosis (PBC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fast Forward Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	FFP104	Cohorts receiving multiple weekly or biweekly i.v. doses of FFP104. FFP104 dose levels: 1.0, 2.5 and 5.0 mg/kg. Subjects will be treated for 12 weeks and then followed for safety and efficacy assessments for an additional 12 weeks.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2014-07-17
• Last updated: 2016-08-24

Locations

5 sites across 2 countries: Netherlands, United Kingdom