Atopic DermatitisPhase 1NCT07920783
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
A Phase 1 study testing GLR2053 Tablets in people with Atopic Dermatitis, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This is a first-in-human (FIH) study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of GLR2053 in healthy male and female adult participants, and to evaluate the effect of a high-fat meal on the pharmacokinetics of GLR2053. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- GLR2053 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2026to 9 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has voluntarily signed the informed consent form prior to any study-related procedure, fully understands the study objectives, procedures, potential risks and restrictions, and is able to communicate effectively with the study personnel and to comply with the protocol requirements.
- Male or female, aged 18 to 55 years (inclusive), at the time of signing the informed consent form.
- Agrees to use protocol-approved highly effective contraceptive methods from the protocol-specified time point until 3 months after the last dose, and not to donate sperm or ova during this period.
Who cannot join
- History of drug or food allergy, or of allergic disease such as bronchial asthma, urticaria, or eczema (mild seasonal allergy to be assessed by the investigator on a case-by-case basis); or known or suspected hypersensitivity or intolerance to GLR2053 or any of its excipients.
- Hospitalization for any reason within 1 month before screening; or, at screening, any unresolved condition, trauma, or surgery that may affect safety or the interpretation of results.
- Clinically significant disease of the cardiovascular, hematologic, respiratory, hepatobiliary, renal, gastrointestinal, endocrine/metabolic, neuropsychiatric, dermatologic, musculoskeletal, or immune system, or any other medical history or current condition that may increase risk or interfere with assessments; or a first-degree relative with a history of, or current, inherited immunodeficiency.
- At screening, clinically significant gastrointestinal dysfunction that may affect drug intake, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, cholecystectomy, gastrectomy, or other gastrointestinal surgery that may affect absorption).
- Major surgery within 3 months before screening, or planned surgery during the study.
- History of drug abuse within 1 year before screening, or a positive drug screen at screening or before dosing.
Show all 18Show fewer
- Average daily consumption of >5 cigarettes or an equivalent amount of nicotine-containing products within 3 months before screening, or inability to discontinue tobacco/nicotine product use during the study.
- History of alcohol abuse within 6 months before screening, a positive breath alcohol test, or inability to abstain from alcohol during the study. Alcohol abuse is defined as >7 units per week for women and >14 units per week for men (1 unit is approximately 285 mL of full-strength beer [4.8% alcohol by volume, ABV], 30 mL of spirits [40% ABV], or 100 mL of wine [13.5% ABV]).
- Women who are pregnant or breastfeeding, or who intend to become pregnant during the protocol-specified contraception period; or a positive high-sensitivity serum beta-human chorionic gonadotropin (β-hCG) test at screening or before dosing.
- Clinically significant abnormal 12-lead ECG, vital sign, physical examination, imaging, or laboratory findings at screening or before dosing, as judged by the investigator; or QTcF >450 ms, or a history of long QT syndrome, torsades de pointes, clinically significant arrhythmia, syncope, or unexplained sudden death in a first-degree relative.
- Positive results at screening for human immunodeficiency virus antigen/antibody, Treponema pallidum antibody, hepatitis B surface antigen, or hepatitis C antibody.
- Donation of >100 mL of blood or blood components, or blood loss of >400 mL, within 2 months before screening; or planned blood donation during the study.
- Participation in another interventional clinical study of a drug, device, or surgical procedure within 3 months before screening or within 5 half-lives of the previous investigational product, whichever is longer; or planned participation in another study before completion of this study.
- Receipt of a live or live-attenuated vaccine within 3 months before the first dose, or of any other vaccine within 1 month before the first dose; or planned vaccination during the study or within 1 month after study completion.
- Food allergy or special dietary requirements incompatible with the standardized diet, or inability to comply with restrictions on fasting, fluid intake, caffeine, alcohol, or activity.
- Intolerance to repeated venipuncture, difficult venous access, or a significant history of needle phobia or blood phobia.
- Any acute illness, or the use of concomitant therapy, occurring between the start of screening and the first dose.
- Any other condition that, in the investigator's opinion, may compromise the rights or welfare of the participant, increase risk, affect compliance, or interfere with the interpretation of study results, or any other reason for which the participant is unable to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing GoBroad Hospital
Beijing
zhuoran Li, 010-56456739, zhuoran.li@ganlee.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of GLR2053 Tablets Following Single and Multiple Dose Administration, and the Effect of Food in Healthy Adult Participants
This is a first-in-human (FIH) study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of GLR2053 in healthy male and female adult participants, and to evaluate the effect of a high-fat meal on the pharmacokinetics of GLR2053.
- Conditions
- Atopic Dermatitis
- Being tested
- GLR2053 Tablets, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLR2053 TabletsDrug
Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053.
PlaceboDrug
Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| GLR2053 Tablets | Experimental | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053. Receives: Drug: GLR2053 Tablets |
| Placebo | Placebo comparator | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs)
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
The incidence of serious adverse events (SAEs)
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Secondary outcomes (16)
Changes in STAT6
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38
Changes in TARC
Measured: MAD:Baseline to Day38
Cmax
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
AUC0-t
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
AUC0-inf
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Tmax
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
λz
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
t1/2
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
CL/F
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Vz/F
Measured: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Changes in IgE
Measured: MAD:Baseline to Day38
Cmax,ss
Measured: MAD:Baseline to Day38
Cmin,ss
Measured: MAD:Baseline to Day38
Cav,ss
Measured: MAD:Baseline to Day38
AUC0-τ,ss
Measured: MAD:Baseline to Day38
Tmax,ss
Measured: Baseline to Day38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start5 Nov 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion9 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920783
- Sponsor's protocol ID
- GLR2053-OOO-101
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of GLR2053 Tablets Following Single and Multiple Dose Administration, and the Effect of Food in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07920783
- Acronym / sponsor ID
- GLR2053-OOO-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 9 Nov 2027 (estimated)
- First posted
- 6 Nov 2026 (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 is a first-in-human (FIH) study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of GLR2053 in healthy male and female adult participants, and to evaluate the effect of a high-fat meal on the pharmacokinetics of GLR2053.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLR2053 Tablets | Experimental | Drug: GLR2053 TabletsEach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053. |
| Placebo | Placebo comparator | Drug: PlaceboEach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has voluntarily signed the informed consent form prior to any study-related procedure, fully understands the study objectives, procedures, potential risks and restrictions, and is able to communicate effectively with the study personnel and to comply with the protocol requirements.
- Male or female, aged 18 to 55 years (inclusive), at the time of signing the informed consent form.
- Agrees to use protocol-approved highly effective contraceptive methods from the protocol-specified time point until 3 months after the last dose, and not to donate sperm or ova during this period.
Key exclusion criteria (18 listed)
- History of drug or food allergy, or of allergic disease such as bronchial asthma, urticaria, or eczema (mild seasonal allergy to be assessed by the investigator on a case-by-case basis); or known or suspected hypersensitivity or intolerance to GLR2053 or any of its excipients.
- Hospitalization for any reason within 1 month before screening; or, at screening, any unresolved condition, trauma, or surgery that may affect safety or the interpretation of results.
- Clinically significant disease of the cardiovascular, hematologic, respiratory, hepatobiliary, renal, gastrointestinal, endocrine/metabolic, neuropsychiatric, dermatologic, musculoskeletal, or immune system, or any other medical history or current condition that may increase risk or interfere with assessments; or a first-degree relative with a history of, or current, inherited immunodeficiency.
- At screening, clinically significant gastrointestinal dysfunction that may affect drug intake, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, cholecystectomy, gastrectomy, or other gastrointestinal surgery that may affect absorption).
- Major surgery within 3 months before screening, or planned surgery during the study.
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 |
|---|---|---|
| GLR2053 TabletsEach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053. | Drug | GLR2053 Tablets |
| PlaceboEach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. | Drug | Placebo |
Primary outcome
The incidence of adverse events (AEs)
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
The incidence of serious adverse events (SAEs)
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
16 secondary outcomes
Changes in STAT6
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38
Changes in TARC
Time frame: MAD:Baseline to Day38
Cmax
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
AUC0-t
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
AUC0-inf
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Tmax
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
λz
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
t1/2
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
CL/F
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Vz/F
Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12
Changes in IgE
Time frame: MAD:Baseline to Day38
Cmax,ss
Time frame: MAD:Baseline to Day38
Cmin,ss
Time frame: MAD:Baseline to Day38
Cav,ss
Time frame: MAD:Baseline to Day38
AUC0-τ,ss
Time frame: MAD:Baseline to Day38
Tmax,ss
Time frame: Baseline to Day38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLR2053 Tablets in people with Atopic Dermatitis, run by Gan & Lee Pharmaceuticals. at 1 site in China.
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 18 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuoran Li (010-56456739, zhuoran.li@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AEs) (time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE：Baseline to Day12). The study lists 2 primary outcomes in all. 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 6 Nov 2026.