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Not yet recruitingPhase 1

First study of GLR2053 tablets in healthy adults, a possible atopic dermatitis treatment

Tests how safe GLR2053 is and how the body handles it in healthy adults.

Key facts

Who runs it
Gan & Lee Pharmaceuticals.
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Status
Not yet recruiting
Phase
Phase 1
People taking part
124 people, planned
Started
5 Nov 2026
Expected to end
9 Nov 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • GLR2053 Tablets
  • Placebo
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adult men and women aged 18 to 55 years to test how safe GLR2053 tablets are and how the body handles them.

Age
18 to 55 years (inclusive)
Sex
Men and women can join.
Earlier treatment
People cannot join if they took part in another drug, device or surgery study within 3 months before screening, or within 5 half-lives of the earlier study drug, whichever is longer. Live vaccines within 3 months and other vaccines within 1 month before the first dose are not allowed.

Main reasons for not taking part

  • Allergy to a drug or food, or an allergic disease such as asthma, urticaria or eczema
  • Pregnant or breastfeeding women, or a positive pregnancy test
  • Positive test for HIV, syphilis, hepatitis B or hepatitis C
  • Clinically significant disease or abnormal heart tracing (QTcF >450 ms)
  • Drug abuse within 1 year or alcohol abuse within 6 months before screening

This trial only enrols healthy participants. The registry sentence this rests on: 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.

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • 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])
  • 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
  • Any acute illness, or the use of concomitant therapy, occurring between the start of screening and the first dose
  • 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
  • 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
  • History of drug abuse within 1 year before screening, or a positive drug screen at screening or before dosing
  • Positive results at screening for human immunodeficiency virus antigen/antibody, Treponema pallidum antibody, hepatitis B surface antigen, or hepatitis C antibody
  • 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 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • GLR2053 TabletsTreatment being tested

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

  • PlaceboPlacebo, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
First study of GLR2053 tablets in healthy adults, a possible atopic dermatitis treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07920783, who can take part
Record updated
6 November 2026