ClinicalTrials.gg
Not yet recruitingNCT07920783Updated Nov 6, 2026

A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants

A Phase 1 interventional study of GLR2053 Tablets and Placebo in Atopic Dermatitis, sponsored by Gan & Lee Pharmaceuticals.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Gan & Lee Pharmaceuticals. · Phase 1, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

Browse trials for

03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 124 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Gan & Lee Pharmaceuticals. is the lead sponsor of 29 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Has voluntarily signed the 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.
  2. Male or female, aged 18 to 55 years (inclusive), at the time of signing the informed consent form.
  3. Agrees to use protocol-approved highly effective methods from the protocol-specified time point until 3 months after the last dose, and not to donate sperm or ova during this period.

Exclusion criteria

Exclusion Criteria:

  1. 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 or intolerance to GLR2053 or any of its .
  2. 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.
  3. 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.
  4. 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).
  5. Major surgery within 3 months before screening, or planned surgery during the study.
  6. History of drug abuse within 1 year before screening, or a positive drug screen at screening or before dosing.
  7. 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.
  8. 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]).
  9. Women who are pregnant or breastfeeding, or who intend to become pregnant during the protocol-specified period; or a positive high-sensitivity serum beta-human chorionic gonadotropin (β-hCG) test at screening or before dosing.
  10. Clinically significant abnormal 12-lead , vital sign, physical examination, imaging, or laboratory findings at screening or before dosing, as judged by the investigator; or >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.
  11. Positive results at screening for antigen/antibody, Treponema pallidum antibody, surface antigen, or antibody.
  12. 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.
  13. 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 product, whichever is longer; or planned participation in another study before completion of this study.
  14. Receipt of a live or 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.
  15. 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.
  16. Intolerance to repeated venipuncture, difficult venous access, or a significant history of needle phobia or blood phobia.
  17. Any acute illness, or the use of concomitant therapy, occurring between the start of screening and the first dose.
  18. 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    GLR2053 Tablets

    Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053.

    Drug: GLR2053 Tablets

  • Placebo comparator
    Placebo

    Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

    Drug: Placebo

Interventions

  • DrugGLR2053 Tablets

    Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GLR2053.

  • DrugPlacebo

    Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

06

What researchers measure

Primary outcomes

  1. The incidence of adverse events (AEs)

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  2. The incidence of serious adverse events (SAEs)

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

Secondary outcomes

  1. Changes in STAT6

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38

  2. Changes in TARC

    Time frame: MAD:Baseline to Day38

  3. Cmax

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  4. AUC0-t

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  5. AUC0-inf

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  6. Tmax

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  7. λz

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  8. t1/2

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  9. CL/F

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  10. Vz/F

    Time frame: SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

  11. Changes in IgE

    Time frame: MAD:Baseline to Day38

  12. Cmax,ss

    Time frame: MAD:Baseline to Day38

  13. Cmin,ss

    Time frame: MAD:Baseline to Day38

  14. Cav,ss

    Time frame: MAD:Baseline to Day38

  15. AUC0-τ,ss

    Time frame: MAD:Baseline to Day38

  16. Tmax,ss

    Time frame: Baseline to Day38

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.

Of 114 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 8 months is below that.

Counting every sponsor, half of 131 studies reached it within 13 months; a quarter within 5 and three quarters within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 6, 2026
StartEst.
Nov 5, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Nov 9, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07920783
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 5, 2026 (estimated)
Primary completion
Jul 30, 2027 (estimated)
Completion
Nov 9, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Zhuoran Li
Contact
zhuoran.li@ganlee.com
010-56456739

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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