Allergic DiseasePhase 1NCT05960708
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
A Phase 1 study testing YH35324 and Omalizumab in people with Allergic Disease and Chronic Spontaneous Urticaria, run by Yuhan Corporation at 9 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria
- 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
- 30 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 23 Aug 2023to 13 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Dong-a University hospital
Busan, 49201
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
Official title: A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases
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.
Read the detailed description
This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. 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
- Being tested
- YH35324, Omalizumab, Placebo
- Keywords
- GI-301, YH35324, Allergic disease, CSU, CINDU, Cold urticaria
- Medical subject headings
- Chronic Urticaria, Chronic Inducible Urticaria, Cold Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH35324Drug
Subcutaneous injection of YH35324
OmalizumabDrug
Also called Xolair® prefilled syringe 150 for injection
Subcutaneous injection of Omalizumab
PlaceboDrug
Subcutaneous injection of None of active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of adverse events (AEs)
To evaluate the safety and tolerability following single administration of YH35324
Measured: Occurrence and severity of adverse events will be observed for 57 days after administration
Secondary outcomes (1)
Change in serum free IgE level
To evaluate the PD profile on serum IgE following single administration of YH35324
Measured: Change in serum free IgE will be observed for 57 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start23 Aug 2023
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hae-Sim Park, Study chair, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960708
- Sponsor's protocol ID
- YH35324-103
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 yjshim@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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases
- ClinicalTrials.gov ID
- NCT05960708
- Acronym / sponsor ID
- YH35324-103
- Conditions
- Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria
- Keywords
- GI-301, YH35324, Allergic disease, CSU, CINDU, Cold urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH35324 | Experimental | Drug: YH35324[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. |
| Omalizumab | Active comparator | Drug: Omalizumab[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. |
| Placebo | Placebo comparator | Drug: Placebo[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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH35324Subcutaneous injection of YH35324 | Drug | YH35324 |
| OmalizumabAlso: Xolair® prefilled syringe 150 for injectionSubcutaneous injection of Omalizumab | Drug | Omalizumab |
| PlaceboSubcutaneous injection of None of active ingredient | Drug | Placebo |
Primary outcome
Occurrence and severity of adverse events (AEs)
Time frame: Occurrence and severity of adverse events will be observed for 57 days after administration
To evaluate the safety and tolerability following single administration of YH35324
1 secondary outcome
Change in serum free IgE level
Time frame: Change in serum free IgE will be observed for 57 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: 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 yjshim@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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae-Sim Park study chair
Ajou University School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YH35324 and Omalizumab in people with Allergic Disease and Chronic Spontaneous Urticaria, 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 7 inclusion and 7 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 22 Nov 2024. 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 57 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.