NCT05442788

A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

A Phase Ib, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following Multiple Dose in Patients With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Huabo Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in patients with moderate to severe plaque psoriasis.

Detailed description

The study is a randomized, double-blinded, placebo-controlled, multiple dose-escalation study to evaluate the safety, tolerability, PK and immunogenicity of HB0017 in patients with Moderate to severe plaque psoriasis be given HB0017 at doses of 150mg, 300mg and 450mg or placebo by SC administration every 3 weeks. Each cohort of 10 subjects is randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. After the evaluation and unblinding is completed at week 12(Day 85), the subjects in placebo group completed all study periods, and the HB0017 group continued to be followed up until the end of week 20(D141).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	HB0017 150mg or matching placebo	Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
BIOLOGICAL	HB0017 300mg or matching placebo	Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
BIOLOGICAL	HB0017 450mg or matching placebo	Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-07-05
• Last updated: 2022-07-07

Locations

1 site across 1 country: China