A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
NCT ID: NCT05960708
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2023-08-23
2024-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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YH35324
\[Part 1\] 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.
YH35324
Subcutaneous injection of YH35324
Omalizumab
\[Part 1\] 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.
Omalizumab
Subcutaneous injection of Omalizumab
Placebo
\[Part 2\] 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.
Placebo
Subcutaneous injection of None of active ingredient
Interventions
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YH35324
Subcutaneous injection of YH35324
Omalizumab
Subcutaneous injection of Omalizumab
Placebo
Subcutaneous injection of None of active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\[Parts 1 and 2 only\]
* Diagnosis of CSU
\[Part 2 only\]
* Experience of inadequately uncontrolled CSU despite use of omalizumab
\[Part 3 only\]
* Diagnosis of chronic inducible urticaria (cold urticaria)
Exclusion Criteria
* 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 potential participation in a clinical trial.
19 Years
75 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Hae-Sim Park
Role: STUDY_CHAIR
Ajou University School of Medicine
Locations
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Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Dong-a University hospital
Busan, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YH35324-103
Identifier Type: -
Identifier Source: org_study_id
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