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

NCT ID: NCT06072157

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-05-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A - Single Ascending Dose (SAD) Intravenous Cohorts

Part A: Healthy adult participants will receive a single intravenous infusion of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 5 cohorts evaluated.

Group Type: EXPERIMENTAL

AK006-IV

Intervention Type: DRUG

Intravenous infusion

Placebo-IV

Intervention Type: DRUG

Intravenous infusion

Part B - Multiple Ascending Dose (MAD) Intravenous Cohorts

Part B: Healthy adult participants will receive multiple intravenous infusions of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 3 cohorts evaluated.

Group Type: EXPERIMENTAL

AK006-IV

Intervention Type: DRUG

Intravenous infusion

Placebo-IV

Intervention Type: DRUG

Intravenous infusion

Part C - Multiple Dose Intravenous Cohort

Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.

Group Type: EXPERIMENTAL

AK006-IV

Intervention Type: DRUG

Intravenous infusion

Placebo-IV

Intervention Type: DRUG

Intravenous infusion

Part D - Single Ascending Dose (SAD) Subcutaneous Cohorts

Part D: Healthy adult participants will receive a single subcutaneous injection of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 2 cohorts evaluated.

Group Type: EXPERIMENTAL

AK006-SC

Intervention Type: DRUG

Subcutaneous

Placebo-SC

Intervention Type: DRUG

Subcutaneous

Interventions

AK006-IV

Intravenous infusion

Intervention Type: DRUG

Placebo-IV

Intravenous infusion

Intervention Type: DRUG

AK006-SC

Subcutaneous

Intervention Type: DRUG

Placebo-SC

Subcutaneous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

To be included in the study, the participant must:

• Weigh between 60 and 120 kg (inclusive) and have a body mass index (BMI) between 20 and 32 kg/m2, inclusive
• Agree (female of childbearing potential or male with female partner of childbearing potential) to use a highly effective method (<1% failure rate) of birth control, if sexually active from screening and for 16 weeks after the last dose of investigational product (IP).

Additionally, to be included in Part A, B and D, the participant must:

• Be in good general health with no significant medical history and has no clinically significant abnormalities on physical examination

Additionally, to be included in Part C, the participant must:

• Have a diagnosis of chronic spontaneous urticaria (CSU) for at least 6 months prior to screening
• Has a diagnosis of moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-AH between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following:

• Presence of hives and itch for ≥6 consecutive weeks at any time prior to the Screening, despite the use of non-sedating H1-AHs. Note: Subject must be on a non-sedating H1-AH for treatment of CSU symptoms at the time of the Screening visit.
• UAS7 score ≥16 with a HSS7 score ≥8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-AH.
• Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study.
• Able and willing to complete a daily electronic diary to collect CSU symptoms for the duration of the study.

Exclusion Criteria

• Female participants who are pregnant, lactating, or planning to become pregnant during the study.
• Abnormal laboratory values, or findings in physical examination, ECG (QTc >450 ms for males and >470 ms for females), or vital signs considered to be clinically significant by the investigator.

Additionally, a participant will be excluded from Part A, B and D, if:

• Received treatment with any prescribed (excluding hormonal contraceptives or hormone replacement therapy [post-menopausal females]) or nonprescribed systemic or topical medication (including herbal product, and vitamins) within 21 days prior to the first dose of IP (excluding acetaminophen).

Additionally, a participant will be excluded from Part C, if:

• Has known or suspected urticarial vasculitis
• Subject has causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria
• Subject has other conditions or diseases that in the investigator's opinion might influence study evaluations and results
• Has any disease or condition (medical or surgical) which, in the opinion of the investigator, or medical monitor, would place the subject at increased risk

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allakos Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 601-001 Healthy Volunteer Clinical Research Unit (Part A, B and D)

Anniston, Alabama, United States

Site 601-004 (Part C)

Birmingham, Alabama, United States

Site 601-008 (Part C)

Scottsdale, Arizona, United States

Site 601-014 (Part C)

Bakersfield, California, United States

Site 601-007 (Part C)

Encino, California, United States

Site 601-015 (Part C)

Upland, California, United States

Site 601-016 (Part C)

Colorado Springs, Colorado, United States

Site 601-006 (Part C)

Overland Park, Kansas, United States

Site 601-019 (Part C)

Lexington, Kentucky, United States

Site 601-003 (Part C)

Baltimore, Maryland, United States

Site 601-012 (Part C)

Boston, Massachusetts, United States

Site 601-023 (Part C)

Troy, Michigan, United States

Site 601-011 (Part C)

St Louis, Missouri, United States

Site 601-020 (Part C)

Brooklyn, New York, United States

Site 601-017 (Part C)

Fargo, North Dakota, United States

Site 601-002 (Part C)

Cincinnati, Ohio, United States

Site 601-018 (Part C)

Portland, Oregon, United States

Site 601-010 (Part C)

El Paso, Texas, United States

Site 601-013 (Part C)

Greenfield, Wisconsin, United States

Site 601-106 (Part C)

Calgary, Alberta, Canada

Site 601-103 (Part C)

London, Ontario, Canada

Site 601-107 (Part C)

Niagara Falls, Ontario, Canada

Site 601-108 (Part C)

Toronto, Ontario, Canada

Site 601-102 (Part C)

Québec, Quebec, Canada

Site 601-105 (Part C)

Québec, Quebec, Canada

Countries

United States; Canada

References

O'Sullivan JA, Youngblood BA, Schleimer RP, Bochner BS. Siglecs as potential targets of therapy in human mast cell- and/or eosinophil-associated diseases. Semin Immunol. 2023 Sep;69:101799. doi: 10.1016/j.smim.2023.101799. Epub 2023 Jul 4.

Reference Type: BACKGROUND

PMID: 37413923 (View on PubMed)

Other Identifiers

AK006-001

Identifier Type: -

Identifier Source: org_study_id