- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960708
A Single Dose, Phase 1 Study of YH35324 in Patients With Various Allergic Diseases
A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients With Various Allergic Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Eunji Song
- Phone Number: +82 2-828-0736
- Email: ejsong@yuhan.co.kr
Study Contact Backup
- Name: JungWook Ahn
- Phone Number: +82 2-828-0734
- Email: ajw8299@yuhan.co.kr
Study Locations
-
-
-
Busan, Korea, Republic of, 49201
- Recruiting
- Dong-A University Hospital
-
Contact:
- Younghee Nam
-
Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
-
Principal Investigator:
- Yousook Cho
-
Seoul, Korea, Republic of, 06591
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Principal Investigator:
- Sookyoung Lee
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
-
Principal Investigator:
- Jungwon Park
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
- Recruiting
- Hallym University Sacred Heart Hospital
-
Contact:
- Joohee Kim
-
Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
- Recruiting
- Hallym University Dongtan Sacred Heart Hospital
-
Contact:
- Jeounghee Choi
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
Principal Investigator:
- Saehoon Kim
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
- Recruiting
- CHA Bundang Medical Center
-
Contact:
- Miae Kim
-
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
- Recruiting
- Ajou University Hospital
-
Principal Investigator:
- Youngmin Ye
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female adults aged ≥ 19 to ≤ 75 years
[Parts 1 and 2 only]
- Diagnosis of CSU at least 6 months prior to screening
- Diagnosis of CSU inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
[Part 2 only]
- Experience of inadequately uncontrolled CSU despite use of omalizumab
[Part 3 only]
- Diagnosis of chronic inducible urticaria (cold urticaria) at least 3 months prior to screening
- Diagnosis of chronic inducible urticaria (cold urticaria) inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
Exclusion Criteria:
- History of malignancy within 5 years from screening
- Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal
[Parts 1 and 2 only]
- Chronic urticaria with clear etiology other than CSU
[Part 3 only]
- Chronic urticaria other than studied chronic inducible urticaria (cold urticaria)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YH35324
[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group. [Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. |
Subcutaneous injection of YH35324
|
Active Comparator: Omalizumab
[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group.
|
Subcutaneous injection of Omalizumab
Other Names:
|
Placebo Comparator: Placebo
[Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. |
Subcutaneous injection of None of active ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence and severity of adverse events (AEs)
Time Frame: Occurrence and severity of adverse events will be observed for 57 days after administration
|
To evaluate the safety and tolerability following single administration of YH35324
|
Occurrence and severity of adverse events will be observed for 57 days after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum free IgE level
Time Frame: Change in serum free IgE will be observed for 57 days after administration
|
To evaluate the PD profile on serum IgE following single administration of YH35324
|
Change in serum free IgE will be observed for 57 days after administration
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Serum Concentration(Cmax)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Area Under the Serum Concentration-Time Curve from Zero to the Time of the Last Quantitative Concentration (AUClast)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUCinf)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Time to Maximum Serum Concentration (Tmax)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Terminal Elimination Rate Constant, Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Apparent Serum Clearance (CL/F)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Apparent Volume of Distribution (Vz/F)
Time Frame: Serum concentrations of YH35324 will be observed for 57 days after administration
|
To evaluate the PK profile following single administration of YH35324
|
Serum concentrations of YH35324 will be observed for 57 days after administration
|
Change in serum total IgE level
Time Frame: Change in serum total IgE will be observed for 57 days after administration
|
To evaluate the exploratory PD profile following single administration of YH35324
|
Change in serum total IgE will be observed for 57 days after administration
|
Change in FcƐRI expression on basophil surface
Time Frame: Change in FcƐRI expression on basophil surface will be observed for 57 days after administration
|
To evaluate the exploratory PD profile following single administration of YH35324
|
Change in FcƐRI expression on basophil surface will be observed for 57 days after administration
|
Change in serum soluble FcƐRI concentration
Time Frame: Change in serum soluble FcƐRI concentration will be observed for 57 days after administration
|
To evaluate the exploratory PD profile following single administration of YH35324
|
Change in serum soluble FcƐRI concentration will be observed for 57 days after administration
|
Change in serum Mas-related G protein-coupled receptor-X2 (MRGPRX2) concentration
Time Frame: Change in serum Mas-related G protein-coupled receptor-X2 (MRGPRX2) concentration will be observed for 57 days after administration
|
To evaluate the exploratory PD profile following single administration of YH35324
|
Change in serum Mas-related G protein-coupled receptor-X2 (MRGPRX2) concentration will be observed for 57 days after administration
|
[Parts 1 and 2 only] Change in Basophil Histamine Release Assay (BHRA)
Time Frame: Change in Basophil Histamine Release Assay (BHRA) will be observed for 57 days after administration
|
To evaluate the exploratory PD profile following single administration of YH35324
|
Change in Basophil Histamine Release Assay (BHRA) will be observed for 57 days after administration
|
Change in the Urticaria Control Test (UCT) score
Time Frame: Change in the Urticaria Control Test (UCT) score will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 * Urticaria Control Test score
|
Change in the Urticaria Control Test (UCT) score will be observed for 57 days after administration
|
Rate of Use of rescue medications
Time Frame: Use of rescue medications will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 for using rescue medications diary
|
Use of rescue medications will be observed for 57 days after administration
|
[Parts 1 and 2 only] Change in weekly Hive Severity Score 7 (HSS7)
Time Frame: Change in weekly Hive Severity Score 7 (HSS7) will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 * Hive Severity Score 7
|
Change in weekly Hive Severity Score 7 (HSS7) will be observed for 57 days after administration
|
[Parts 1 and 2 only] Change in weekly Itch Severity Score 7 (ISS7)
Time Frame: Change in weekly Itch Severity Score 7 (ISS7) will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 * Itch Severity Score 7
|
Change in weekly Itch Severity Score 7 (ISS7) will be observed for 57 days after administration
|
[Parts 1 and 2 only] Change in weekly Urticaria Activity Score 7 (UAS7)
Time Frame: Change in weekly Urticaria Activity Score 7 (UAS7) will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 * Urticaria Activity Score 7
|
Change in weekly Urticaria Activity Score 7 (UAS7) will be observed for 57 days after administration
|
[Part 3 only] Change in Critical Temperature Thresholds (CTT) in response to the challenge test (TempTest® 4)
Time Frame: Change in Critical Temperature Thresholds (CTT) in response to the challenge test (TempTest® 4) will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324
|
Change in Critical Temperature Thresholds (CTT) in response to the challenge test (TempTest® 4) will be observed for 57 days after administration
|
[Part 3 only] Change in the Peak Pruritus Numerical Rating Scale (PP-NRS) score after the challenge test (TempTest® 4)
Time Frame: Change in the Peak Pruritus Numerical Rating Scale (PP-NRS) score after the challenge test (TempTest® 4) will be observed for 57 days after administration
|
To explore the clinical efficacy following single administration of YH35324 * Peak Pruritus Numerical Rating Scale
|
Change in the Peak Pruritus Numerical Rating Scale (PP-NRS) score after the challenge test (TempTest® 4) will be observed for 57 days after administration
|
Incidence of serum anti-YH35324 antibodies
Time Frame: Incidence of serum anti-YH35324 antibodies will be observed for 57 days after administration
|
To explore the immunogenicity following single administration of YH35324
|
Incidence of serum anti-YH35324 antibodies will be observed for 57 days after administration
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hae-Sim Park, Ajou University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Disease Attributes
- Skin Diseases, Vascular
- Hypersensitivity
- Chronic Disease
- Urticaria
- Chronic Urticaria
- Chronic Inducible Urticaria
- Cold Urticaria
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Omalizumab
Other Study ID Numbers
- YH35324-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to yjshim@yuhan.co.kr
A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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