NCT05504317

A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis

Detailed description

This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	AK111	Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.
DRUG	Placebo	Subjects will receive corresponding dose of placebo injection subcutaneously.

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2022-08-17
• Last updated: 2025-03-05

Locations

2 sites across 1 country: China