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

Primary Purpose

Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YH35324

Omalizumab

Placebo

About this trial

This is an interventional treatment trial for Allergic Disease focused on measuring GI-301, YH35324, Allergic disease, CSU, CINDU, Cold urticaria

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul National University Bundang HospitalRecruiting
Ajou University HospitalRecruiting
Severance Hospital, Yonsei University Health SystemRecruiting
Asan Medical CenterRecruiting
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

YH35324

Omalizumab

Placebo

Arm Description

[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group. [Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group.

[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group.

[Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group.

Outcomes

Primary Outcome Measures

Occurrence and severity of adverse events (AEs)

To evaluate the safety and tolerability following single administration of YH35324

Secondary Outcome Measures

Change in serum free IgE level

To evaluate the PD profile on serum IgE following single administration of YH35324

Full Information

NCT ID

NCT05960708

First Posted

July 13, 2023

Last Updated

September 25, 2023

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05960708

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 23, 2023 (Actual)

Primary Completion Date

March 13, 2024 (Anticipated)

Study Completion Date

March 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria

Keywords

GI-301, YH35324, Allergic disease, CSU, CINDU, Cold urticaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

YH35324

Arm Type

Experimental

Arm Description

Arm Title

Omalizumab

Arm Type

Active Comparator

Arm Description

[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

YH35324

Intervention Description

Subcutaneous injection of YH35324

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair® prefilled syringe 150 for injection

Intervention Description

Subcutaneous injection of Omalizumab

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous injection of None of active ingredient

Primary Outcome Measure Information:

Title

Occurrence and severity of adverse events (AEs)

Description

To evaluate the safety and tolerability following single administration of YH35324

Time Frame

Occurrence and severity of adverse events will be observed for 57 days after administration

Secondary Outcome Measure Information:

Title

Change in serum free IgE level

Description

To evaluate the PD profile on serum IgE following single administration of YH35324

Time Frame

Change in serum free IgE will be observed for 57 days after administration

Other Pre-specified Outcome Measures:

Title

Maximum Serum Concentration(Cmax)

Description