NCT03768219

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Aptevo Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple doses of APVO210 in psoriasis patients and ulcerative colitis patients.

Conditions

• Psoriasis
• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	APVO210	APVO210
BIOLOGICAL	Placebo	Placebo is saline based IV infusion, and is identical in appearance to active study drug.

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-12-07
• Last updated: 2021-05-19

Locations

1 site across 1 country: Australia