A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

Sponsor

Yuhan Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05061524

Collaborator

(none)

Enrollment

Locations

Arms

14.8

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

Condition or Disease	Intervention/Treatment	Phase
Atopic Healthy Subjects Adult Subjects With Mild Allergic Diseases	Drug: YH35324 Drug: Placebo Drug: Omalizumab	Phase 1

Detailed Description

YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens Based on its non-clinical study results, this study aims to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic diseases.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A First-in-Human, Randomized, Double-Blind, Placebo/Active Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

Actual Study Start Date :

Sep 26, 2021

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YH35324 Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed	Drug: YH35324 Subcutaneous injection of YH35324
Placebo Comparator: Placebo Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: Placebo is not administered in Part B	Drug: Placebo Subcutaneous injection of None of active ingredient
Active Comparator: Xolair® for injection (Omalizumab) Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously.	Drug: Omalizumab Subcutaneous injection of Omalizumab Other Names: Xolair® for injection

Arm

Intervention/Treatment

Experimental: YH35324

Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed

Drug: YH35324

Subcutaneous injection of YH35324

Placebo Comparator: Placebo

Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: Placebo is not administered in Part B

Drug: Placebo

Subcutaneous injection of None of active ingredient

Active Comparator: Xolair® for injection (Omalizumab)

Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously.

Drug: Omalizumab

Subcutaneous injection of Omalizumab

Other Names:

Xolair® for injection

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability following single administration of YH35324 [Occurrence and severity of adverse events will be observed for 113 days after administration]
Occurrence and severity of adverse events (AEs)

Secondary Outcome Measures

To evaluate the PK of YH35324 [Serum concentrations of YH35324 will be observed for 113 days after administration]
Serum concentrations of YH35324
To evaluate the PD of YH35324 [Change in serum Free/Total IgE level will be observed for 113 days after administration]
Change in serum Free/Total IgE level

Other Outcome Measures

To explore the PD of YH35324 [Changes in FcεRI expression will be observed for 57days after administration]
Changes in FcεRI expression
To explore inhibition on allergens (allergy antigens) of YH35324 [Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration]
Changes in allergen-induced skin prick wheal response
To explore the immunogenicity of YH35324 [Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration]
Incidence of serum Anti-YH35324 antibodies
To explore inhibition on allergens (allergy antigens) of YH35324 [Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administration]
Changes in serum allergen specific IgE level

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

19~55 years old, Atopic Healthy Subjects or Subjects With Mild Allergic Diseases
Serum total IgE level of 30 to 700 IU/mL or > 700 IU/mL
Signed the informed consent form

Exclusion Criteria:

Hyperimmunoglobulin E syndrome or malignancy
Positive drug screen result
AST or ALT > 1.5 * Upper normal range
eGFR < 60mL/min/1.73m2
Allergy immunotherapy initiated or Administration of a live vaccine within 3 months prior to randomization
History of participation in another clinical trial within 6 months prior to randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon-si	Gyeonggi-do	Korea, Republic of	16499
2	Asan Medical Center	Pungnap-tong	Seoul	Korea, Republic of	05505
3	Severance Hospital, Yonsei University Health System	Sinchon-dong	Seoul	Korea, Republic of	03722
4	Seoul National University Bundang Hospital	Gumi	Sungnamsi	Korea, Republic of	13620

Sponsors and Collaborators

Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuhan Corporation

ClinicalTrials.gov Identifier:

NCT05061524

Other Study ID Numbers:

YH35324-101

First Posted:

Sep 29, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Omalizumab

Study Results

No Results Posted as of Jan 11, 2022