NCT06072157

Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AK006 in Healthy Subjects and in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. The study will be conducted in 4 parts: a single-ascending dose part (Part A) in healthy participants, a multiple-ascending dose part (Part B) in healthy participants with an expanded cohort (Part C) in participants with chronic spontaneous urticaria (CSU), and a single ascending dose SC injection cohort (Part D) in healthy participants.

Conditions

• Healthy Participants
• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	AK006-IV	Intravenous infusion
DRUG	Placebo-IV	Intravenous infusion
DRUG	AK006-SC	Subcutaneous
DRUG	Placebo-SC	Subcutaneous

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2023-10-10
• Last updated: 2025-06-03

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study