A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

Phase 1

Completed

• Conditions: Chronic Spontaneous Urticaria; Chronic Inducible Urticaria; Cold Urticaria; Allergic Disease
• Interventions: Drug: YH35324; Drug: Omalizumab; Drug: Placebo

• Registration Number: NCT05960708
• Lead Sponsor: Yuhan Corporation

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Study Start: 2023-08-23
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH35324	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.
Omalizumab	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	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.

Primary Outcome Measures

Name	Time	Method
Occurrence and severity of adverse events (AEs)	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

Secondary Outcome Measures

Name	Time	Method
Change in serum free IgE level	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

Trial Locations

Locations (9)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Hwaseong-si, Gyeonggi-do, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Dong-a University hospital; 🇰🇷 Busan, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of