A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

NCT05564221 | Completed Phase 1 DMC

• 1 other identifier: YH35324-102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 9

Brief Summary

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Conditions

Atopic Healthy Subjects; Adult Subjects With Allergic Diseases

Keywords

GI-301; YH35324; Allergic disease

Outcome Measures

Primary Outcomes (1)

• Occurrence and severity of adverse events (AEs)

  To evaluate the safety and tolerability following multiple administrations of YH35324

  Occurrence and severity of adverse events will be observed for 141 days after administration in Cohorts 1 to 5

Secondary Outcomes (20)

• 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 141 days after administrationin in Cohorts 1 to 4

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

  Serum concentrations of YH35324 will be observed for 141 days after administration in Cohorts 1 to 4

• Maximum Serum Concentration(Cmax)

  Serum concentrations of YH35324 will be observed for 141 days after administration in Cohorts 1 to 4

• Time to Maximum Serum Concentration (Tmax)

  Serum concentrations of YH35324 will be observed for 141 days after administration in Cohorts 1 to 4

• Terminal Elimination Rate Constant, Apparent Terminal Elimination Half-life (t1/2)

  Serum concentrations of YH35324 will be observed for 141 days after administration in Cohorts 1 to 4

Other Outcomes (6)

• Changes in FcεRI expression on basophil surface

  Changes in FcεRI expression will be observed for 141days after administrationin in Cohorts 1 to 4

• Changes in allergen-induced skin prick wheal response

  Changes in allergen-induced skin prick wheal response will be observed for 113 days in Cohorts 1 to 5

• Changes in serum allergen specific IgE level

  Changes in allergen-induced serum allergen specific IgE level will be observed for 141 days after administration in Cohorts 1 to 5

Study Arms (3)

YH35324

EXPERIMENTAL

There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.

Drug: YH35324

Placebo

PLACEBO COMPARATOR

There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.

Drug: Placebo

Omalizumab

ACTIVE COMPARATOR

For Cohort 3, omalizumab 300 mg will be administered in an open-label manner.

Drug: Omalizumab

Interventions

YH35324 DRUG

Subcutaneous injection of YH35324

YH35324

Placebo DRUG

Subcutaneous injection of None of active ingredient

Placebo

Omalizumab DRUG

Subcutaneous injection of Omalizumab

Also known as: Xolair® prefilled syringe 150 for injection

Omalizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults aged ≥ 19 to ≤ 55 years(Cohort 5, Mald or female adults ≥ 19)
• Serum total IgE level ≥ 30 IU/mL or 30 to 700 IU/mL or \>700IU/mL(Not Applicable for Cohort 5)
• Meeting the following cohort-specific disease severity criteria \[Cohorts 1-4\]: Healthy subjects without any pathological symptoms or findings from medical examination, or subjects with a history of mild allergic diseases (allergic rhinitis, atopic dermatitis, food allergy, urticaria, or allergic asthma) \[Cohort 5\]: Subject who have been diagnosed with moderate to severe atopic dermatitis

You may not qualify if:

• History of malignancy
• Positive drug screen result
• transaminase (AST) or alanine transaminase (ALT) level \> 2 X the upper limit of normal
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Allergy immunotherapy initiated or changed within 6 months prior to randomization(For Cohort 5, within 12 months prior to randomization)
• History of participation in another clinical trial within 6 months prior to randomization

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (9)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, 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

Nowon Eulji Medical Center

Seoul, 01830, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, 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

Interventions

Omalizumab; Injections

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: As the YH35324 group and placebo group will be double-blinded, YH35324 and placebo will have the same appearance and packaging. Therefore, the double-blind will apply to the subjects, investigators, study coordinators, and study personnel including study pharmacists. The active control omalizumab has a different appearance and packaging from YH35324 and placebo, and will be administered in an open-label manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 3, 2022
• Study Start: November 1, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: January 24, 2025

Record last verified: 2024-12

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 yhcho@yuhan.co.kr

Locations

KR (9)