A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria

Inclusion Criteria:

1. Adults (≥ 18 and ≤ 85 years old)
2. Body weight <125 Kg
3. Informed consent signed and dated
4. Able to read, understand, and willing to sign the informed consent form and complywith study procedures
5. Diagnosis of CU for at least three months, refractory to antihistamine treatment insingle or 4-fold dosage
6. Willing, committed, and able to return for all clinic visits and complete allstudy-related procedures, including willingness to have IV infusion of study drugadministered by a qualified person
7. Females of childbearing potential must have a negative pregnancy test at Baseline.Female subjects must be willing to use highly effective contraception (Pearl- 4 Index < 1). A woman will be considered not of childbearing potential if she ispost-menopausal for greater than two years (FSH >40mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
8. No participation in other clinical trials 4 weeks before participation in this study
9. Uncontrolled CU (UCT <12) at the time of enrollment

Exclusion Criteria:

1. Acute urticaria
2. Concurrent/ongoing treatment with immunosuppressives (e.g., cyclosporine,methotrexate, dapsone, or others) within 4 weeks or 5 half-lives prior to Baseline,whichever is longer
3. Significant medical condition rendering the patient immunocompromised or not suitablefor a clinical trial
4. Significant concomitant illness that would adversely affect the subject'sparticipation or evaluation in this study
5. History of malignancies within five years prior to screening other than a successfullytreated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situcancer
6. Presence of clinically significant laboratory abnormalities
7. Lactating women or pregnant women
8. Substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatriccondition) within the last 5 years that could limit the subject's ability to complywith study procedures
9. Subjects who are detained officially or legally to an official institute or those thathave been committed to an institution by virtue of an order issued either by thejudicial or the administrative authorities will be excluded from the study
10. Use of omalizumab within the last 3 months
11. Receipt of intravenous IgG therapy 30 days prior to Baseline
12. Plasmapheresis 30 days prior to Baseline
13. Use (daily or every other day) of Doxepin 14 days prior to Baseline
14. Receipt of inactive vaccination or live attenuated vaccine 30 days prior to Baseline
15. Use of H2 antihistamines 7 days before Baseline
16. Intake of leukotriene antagonists within 7 days prior to enrollment
17. Intake of systemic corticosteroids (e.g., oral or depot) within 14 days prior toenrollment
18. Positive screening for ova and parasite test at Baseline
19. Treatment of helminthic parasite within 6 months of screening
20. Positive HIV serology at screening
21. Positive Hepatitis serology at baseline, except for vaccinated patients or patientswith past but resolved hepatitis at screening
22. Donation or loss of >500ml of blood within 56 days prior to administration of studydrug or donation of plasma within 7 days prior to administration of drug
23. Known hypersensitivity to any ingredients of AK002 or drugs related to AK002 (e.g.,monoclonal antibodies, polyclonal gamma globulin)