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Starting soon Phase 1

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

NCT07920783 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-11-05
Last updated
2026-11-06

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

GLR2053 TabletsPlacebo

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 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. 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 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. 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 hypersensitivity or intolerance to GLR2053 or any of its excipients. 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. 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. 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 contraception 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 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. 11. Positive results at screening for human immunodeficiency virus antigen/antibody, Treponema pallidum antibody, hepatitis B surface antigen, or hepatitis C 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 investigational product, whichever is longer; or planned participation in another study before completion of this study. 14. 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. 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.

Primary outcome measure(s)

  • The incidence of adverse events (AEs) — SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12
  • The incidence of serious adverse events (SAEs) — SAD:Baseline to Day14 MAD:Baseline to Day38 FE:Baseline to Day12

Trial sites (1)

FacilityCityRegionStatus
Beijing GoBroad Hospital Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07920783 on ClinicalTrials.gov ↗ ← All trials in China