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This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.
This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH35324 | Experimental | [Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group. [Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. |
|
| Omalizumab | Active Comparator | [Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group. |
|
| Placebo | Placebo Comparator | [Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH35324 | Drug | Subcutaneous injection of YH35324 |
| |
| Omalizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of adverse events (AEs) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum free IgE level | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration(Cmax) | 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) |
Inclusion Criteria:
[Parts 1 and 2 only]
[Part 2 only]
[Part 3 only]
Exclusion Criteria:
[Parts 1 and 2 only]
[Part 3 only]
The above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Hae-Sim Park | Ajou University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 14068 | South Korea | ||
| Hallym University Dongtan Sacred Heart Hospital |
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.
Beginning 1 year and ending 5 years after all trial 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
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Each IP will be labeled with a unique IP number, and the number will be associated with the randomized treatment group. Interactive Web Response System (IWRS) will be used to assign a randomization number and IP number.
As YH35324, placebo, and omalizumab differ in appearance, the assigned treatment group of subjects should be disclosed to study pharmacists and unblinded staff who prepare (taking an appropriate and correct amount (mL) of the IP based on the subject's body weight into a syringe), dispense, and administer the IPs, in order to maintain the blind. Therefore, the treatment group information of subjects will be checked through IWRS with limited access before administration of the IP, and only study pharmacists and unblinded staff are allowed to access the system.
The study pharmacists and unblinded staff should not disclose the assigned treatment group of enrolled subjects to the principal investigator or study staff.
| Drug |
Subcutaneous injection of Omalizumab |
|
|
| Placebo | Drug | Subcutaneous injection of None of active ingredient |
|
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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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 | To explore the immunogenicity following single administration of YH35324 | Incidence of serum anti-YH35324 antibodies will be observed for 57 days after administration |
| Hwaseong-si |
| Gyeonggi-do |
| 18450 |
| South Korea |
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Dong-a University hospital | Busan | 49201 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D000094482 | Chronic Inducible Urticaria |
| D000096703 | Cold Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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