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Atopic Healthy SubjectsPhase 1NCT05564221

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

A Phase 1 study testing YH35324 and Omalizumab in people with Atopic Healthy Subjects and Adult Subjects With Allergic Diseases, run by Yuhan Corporation at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
YH35324 and Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
9 sitesSouth Korea
Study dates
1 Nov 2022to 28 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 14584

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Nowon Eulji Medical Center

    Seoul, 01830

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

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

    Seoul, 06591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blind, Placebo/Active Controlled, Multiple Ascending Dose, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

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.

Read the 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. 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.

Being tested
YH35324, Placebo, Omalizumab
Keywords
GI-301, YH35324, Allergic disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YH35324Drug

    Subcutaneous injection of YH35324

  • PlaceboDrug

    Subcutaneous injection of None of active ingredient

  • OmalizumabDrug

    Also called Xolair® prefilled syringe 150 for injection

    Subcutaneous injection of Omalizumab

Study groups in NCT05564221
Study groupRoleWhat they receive
YH35324ExperimentalThere 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.
Receives: Drug: YH35324
PlaceboPlacebo comparatorThere 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.
Receives: Drug: Placebo
OmalizumabActive comparatorFor Cohort 3, omalizumab 300 mg will be administered in an open-label manner.
Receives: Drug: Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence and severity of adverse events (AEs)

    To evaluate the safety and tolerability following multiple administrations of YH35324

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

Secondary outcomes (20)

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

    To evaluate the PK profile of YH35324

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

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

    To evaluate the PK profile of YH35324

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

  3. Maximum Serum Concentration(Cmax)

    To evaluate the PK profile of YH35324

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

  4. Time to Maximum Serum Concentration (Tmax)

    To evaluate the PK profile of YH35324

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

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

    To evaluate the PK profile of YH35324

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

  6. Apparent Serum Clearance (CL/F)

    To evaluate the PK profile of YH35324

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

  7. Apparent Volume of Distribution (Vz/F)

    To evaluate the PK profile of YH35324

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

  8. Area Under the Serum Concentration-Time Curve during dosing interval at steady-state (AUCtau)

    To evaluate the PK profile of YH35324

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

  9. Maximum Serum Concentration at steady-state (Cmax,ss)

    To evaluate the PK profile of YH35324

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

  10. Time to Maximum Serum Concentration at steady-state (Tmax,ss)

    To evaluate the PK profile of YH35324

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

  11. Accumulation ratio (Rac)

    To evaluate the PK profile of YH35324

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

  12. Change in serum free IgE level

    To evaluate the PD profile on serum IgE following multiple administrations of YH35324

    Measured: Change in serum Free IgE will be observed for 141 days after administration in Cohorts 1 to 5

  13. Change in serum total IgE level

    To evaluate the PD profile on serum IgE following multiple administrations of YH35324

    Measured: Change in serum Total IgE will be observed for 141 days after administration in Cohorts 1 to 4

  14. Serum concentrations of YH35324

    To evaluate the PK profile of YH35324

    Measured: Serum concentrations of YH35324 will be observed for 99 days after administration in Cohorts 5

  15. Change in Eczema Area and Severity Index (EASI)

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Change in Eczema Area and Severity Index (EASI) will be observed for 141 days after administration in Cohorts 5

  16. Change in Validated Investigator Global Assessment (vIGA-AD)

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Change in Validated Investigator Global Assessment (vIGA-AD) will be observed for 141 days after administration in Cohorts 5

  17. Change in SCORing Atopic Dermatitis (SCORAD)

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Change in SCORing Atopic Dermatitis (SCORAD) will be observed for 141 days after administration in Cohorts 5

  18. Change in Pruritus-Numerical Rating Scale (NRS)

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Change in Pruritus-Numerical Rating Scale (NRS) will be observed for 141 days after administration in Cohorts 5

  19. Change in body surface area (BSA) of atopic dermatitis involvement

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Change in body surface area (BSA) of atopic dermatitis involvement will be observed for 141 days after administration in Cohorts 5

  20. Number of days of rescue treatment (TCS or TCI) used

    To explore the clinical efficacy following multiple administrations of YH35324

    Measured: Number of days of rescue treatment (TCS or TCI) used will be observed for 141 days after administration in Cohorts 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion28 Nov 2024
  4. Study completion28 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564221
Sponsor's protocol ID
YH35324-102
Status last verified
Dec 2024
First submitted
19 Sep 2022
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. 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. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH35324 and Omalizumab in people with Atopic Healthy Subjects and Adult Subjects With Allergic Diseases, run by Yuhan Corporation at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence and severity of adverse events (AEs) (time frame: Occurrence and severity of adverse events will be observed for 141 days after administration in Cohorts 1 to 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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