Clinical trial NCT05061524: A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Healthy Subjects
Adult Subjects with Mild Allergic Diseases
Keywords: YH35324
GI-301
Allergic disease
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the safety and tolerability following single administration of YH35324
timeFrame: Occurrence and severity of adverse events will be observed for 113 days after administration
Secondary outcomes:
measure: To evaluate the PK of YH35324
timeFrame: Serum concentrations of YH35324 will be observed for 113 days after administration
measure: To evaluate the PD of YH35324
timeFrame: Change in serum Free/Total IgE level will be observed for 113 days after administration
Other outcomes:
measure: To explore the PD of YH35324
timeFrame: Changes in FcεRI expression will be observed for 57days after administration
measure: To explore inhibition on allergens (allergy antigens) of YH35324
timeFrame: Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration
measure: To explore the immunogenicity of YH35324
timeFrame: Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration
measure: To explore inhibition on allergens (allergy antigens) of YH35324
timeFrame: Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administration
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Pungnap-tong
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Sinchon-dong
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul
city: Gumi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Sungnamsi
Study officials:
References: