Atopic Healthy SubjectsPhase 1NCT05061524
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
A Phase 1 study testing YH35324 and Omalizumab in people with Atopic Healthy Subjects and Adult Subjects with Mild Allergic Diseases, run by Yuhan Corporation at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Healthy Subjects, Adult Subjects with Mild Allergic Diseases
- 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
- 68 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 26 Sep 2021to 25 Jan 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Gumi, Sungnamsi, 13620
Asan Medical Center
Pungnap-tong, Seoul, 05505
Severance Hospital, Yonsei University Health System
Sinchon-dong, Seoul, 03722
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
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
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.
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 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.
- Being tested
- YH35324, Placebo, Omalizumab
- Keywords
- YH35324, GI-301, 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® for injection
Subcutaneous injection of Omalizumab
| Study group | Role | What they receive |
|---|---|---|
| YH35324 | Experimental | * Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses
* Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed Receives: Drug: YH35324 |
| Placebo | Placebo comparator | * Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses
* Part B: Placebo is not administered in Part B Receives: Drug: Placebo |
| Xolair® for injection (Omalizumab) | Active comparator | * Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg)
* Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability following single administration of YH35324
Occurrence and severity of adverse events (AEs)
Measured: Occurrence and severity of adverse events will be observed for 113 days after administration
Secondary outcomes (2)
To evaluate the PK of YH35324
Serum concentrations of YH35324
Measured: Serum concentrations of YH35324 will be observed for 113 days after administration
To evaluate the PD of YH35324
Change in serum Free/Total IgE level
Measured: Change in serum Free/Total IgE level will be observed for 113 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 posted29 Sep 2021
- Study start26 Sep 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Healthy SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061524
- Sponsor's protocol ID
- YH35324-101
- Status last verified
- Nov 2024
- First submitted
- 16 Sep 2021
- Last updated
- 3 Dec 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05061524
- Acronym / sponsor ID
- YH35324-101
- Keywords
- YH35324, GI-301, Allergic disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 29 Sep 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH35324 | Experimental | Drug: YH35324* Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed |
| Placebo | Placebo comparator | Drug: Placebo* Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: Placebo is not administered in Part B |
| Xolair® for injection (Omalizumab) | Active comparator | Drug: Omalizumab* Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) * Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
| PlaceboSubcutaneous injection of None of active ingredient | Drug | Placebo |
| OmalizumabAlso: Xolair® for injectionSubcutaneous injection of Omalizumab | Drug | Xolair® for injection (Omalizumab) |
Primary outcome
To evaluate the safety and tolerability following single administration of YH35324
Time frame: Occurrence and severity of adverse events will be observed for 113 days after administration
Occurrence and severity of adverse events (AEs)
2 secondary outcomes
To evaluate the PK of YH35324
Time frame: Serum concentrations of YH35324 will be observed for 113 days after administration
To evaluate the PD of YH35324
Time frame: Change in serum Free/Total IgE level will be observed for 113 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 3 Dec 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 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Atopic Healthy Subjects and Adult Subjects with Mild Allergic Diseases, run by Yuhan Corporation at 4 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
To evaluate the safety and tolerability following single administration of YH35324 (time frame: Occurrence and severity of adverse events will be observed for 113 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 3 Dec 2024.