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

NCT05960708 | Completed Phase 1

• 1 other identifier: YH35324-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

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.

Conditions

Allergic Disease; Chronic Spontaneous Urticaria; Chronic Inducible Urticaria; Cold Urticaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Occurrence and severity of adverse events (AEs)

  To evaluate the safety and tolerability following single administration of YH35324

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

Secondary Outcomes (1)

• Change in serum free IgE level

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

Other Outcomes (20)

• Maximum Serum Concentration(Cmax)

  Serum concentrations of YH35324 will be observed for 57 days after administration

• Area Under the Serum Concentration-Time Curve from Zero to the Time of the Last Quantitative Concentration (AUClast)

  Serum concentrations of YH35324 will be observed for 57 days after administration

• Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUCinf)

  Serum concentrations of YH35324 will be observed for 57 days after administration

Study Arms (3)

YH35324

EXPERIMENTAL

\[Part 1\] 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.

Drug: YH35324

Omalizumab

ACTIVE COMPARATOR

\[Part 1\] 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.

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

\[Part 2\] 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.

Drug: Placebo

Interventions

YH35324 DRUG

Subcutaneous injection of YH35324

YH35324

Omalizumab DRUG

Subcutaneous injection of Omalizumab

Also known as: Xolair® prefilled syringe 150 for injection

Omalizumab

Placebo DRUG

Subcutaneous injection of None of active ingredient

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (9)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Dong-a University hospital

Busan, 49201, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Chronic Urticaria; Chronic Inducible Urticaria; Cold Urticaria

Interventions

Omalizumab; Injections

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hae-Sim Park

  Ajou University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 27, 2023
• Study Start: August 23, 2023
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 1 year and ending 5 years after all trial endpoints were assessed
• Access Criteria: Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to yjshim@yuhan.co.kr

Locations

KR (9)