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
Status: Completed
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 75
Healthy Volunteers: f
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• Male or female adults aged ≥ 19 to ≤ 75 years
⁃ \[Parts 1 and 2 only\]
• 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)
Locations
Other Locations
Republic of Korea
Hallym University Sacred Heart Hospital
Anyang-si
Dong-a University hospital
Busan
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
CHA Bundang Medical Center
Seongnam-si
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Ajou University Hospital
Suwon
Time Frame
Start Date: 2023-08-23
Completion Date: 2024-09-13
Participants
Target number of participants: 30
Treatments
Experimental: 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.
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Yuhan Corporation