A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
Key facts
- Who runs it
- Yuhan Corporation
- Where
- South Korea9 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 30 people enrolled
- Started
- 23 Aug 2023
- Ended
- 13 Sept 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- YH35324
- Omalizumab
- Placebo
- Record updated
- 22 November 2024
Who can take part
- Age
- 19 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 potential participation in a clinical trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- YH35324Treatment being tested
\[Part 1\] 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.
- OmalizumabExisting treatment, for comparison
\[Part 1\] 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.
- PlaceboPlacebo, for comparison
\[Part 2\] 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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 22 November 2024