Loading clinical trials...

COMPLETEDPHASE1

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

NCT06072157•Allakos Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

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

Locations (25)

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

Key Dates

Start Date

August 28, 2023

Primary Completion Date

May 12, 2025

Completion Date

May 12, 2025

Last Updated

June 3, 2025

Enrollment

136

ACTUAL participants

Conditions

Healthy ParticipantsChronic Spontaneous Urticaria

Interventions

AK006-IV

DRUG

Placebo-IV

DRUG

AK006-SC

DRUG

Placebo-SC

DRUG

A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity

NCT07310901

Obese But Otherwise Healthy Participants

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

Study of BW-50218 in Healthy Participants

A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults.