Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
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Keep this study
Lead
Allakos Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
