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NCT Number: NCT06554054

A Study of GZR18 Tablet in Chinese Healthy Subjects

The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study Site 01

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects sign informed consent voluntarily.
  • Age 18-55 at screening (both included),male or female(male only for part A).
  • At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
  • Female subjects were HCG negative at screening and baseline

Exclusion criteria

  • Female subjects who are pregnant or lactating at screening.
  • History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
  • Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
  • History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
  • Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.

Treatment and study plan

GZR18

Drug

Oral administered the GZR18 tablet

Primary outcomes

  1. AE and SAE

    Time frame: 22 days and 35 days

    Incidence of Adverse Events and Severe Adverse Events

  2. Relative bioavailability of GZR18 tablet

    Time frame: 22 days and 35 days

    Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%

  3. ADA and NAb

    Time frame: 22 days and 35 days

    Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)

Secondary outcomes

  1. Cmax

    Time frame: 22 days and 35 days

    Maximum plasma drug concentration

  2. AUC0-t

    Time frame: 22 days and 35 days

    Area under the curve from 0 through the time of the last accurately measurable concentration

  3. AUC0-24h

    Time frame: 22 days and 35 days

    Area under the curve from 0 h to 24 hours

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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