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Completed

NCT Number: NCT07119450

The Study of [14C] GZR18

This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study.

The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Study site 01

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must be fully informed, know and understand the content, process and possible treatment-related adverse events (TRAEs) before the study, and voluntarily sign a written informed consent form;
  • Chinese adult male subjects aged 18-55 (inclusive);
  • Body weight ≥ 50 kg;
  • Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);
  • Subjects have no sperm donation plan within 6 months after the last dose, and subjects and their partners have no pregnancy plan throughout the study and within 6 months after the last dose and voluntarily take effective contraceptive measures to avoid pregnancy of their partners.

Exclusion criteria

  • Subjects with other clinically significant diseases or medical history that may hinder the subject from following the study protocol and completing this study as judged by the investigator.
  • Subjects with abnormalities in vital signs, physical examination, routine laboratory tests (hematology, urinalysis, stool analysis + occult blood, blood chemistry and coagulation function), chest X-ray (AP view) or abdominal B-scan ultrasonography at screening or baseline, which are deemed clinically significant by the investigator; subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin exceeding the normal range at screening/baseline, which are deemed clinically significant by the investigator.
  • Subjects who suffer from dyspepsia, esophageal reflux, peptic ulcer or gallbladder disease within 3 months prior to dosing, or any gastrointestinal disease that may affect gastric emptying, or any surgical procedure (such as cholecystectomy, except for appendicitis surgery) that may affect drug metabolism or excretion; or plan to undergo surgery during the study.
  • Subjects who used any prescription drugs, OTC drugs, Chinese herbal medicines, food supplements (including vitamins, health food, etc.) within 14 days before dosing, or have other non-drug therapeutic factors affecting drug absorption, distribution, metabolism and excretion.
  • ubjects who have received any other investigational drug or participated in any other interventional clinical study within 3 months prior to screening, or still within 5 half-lives of a previously administered investigational drug at screening, whichever is longer.
  • Difficulty in blood collection or intolerance to venipuncture for blood collection.
  • Subjects who smoked > 5 cigarettes/day on average (or used an equivalent amount of nicotine products) in 6 months prior to screening, or are unwilling to abstain from tobacco products during the study.
  • Those who are not eligible for the study for other reasons as judged by the investigator.

Treatment and study plan

GZR18 injection、[14C]GZR18 injection

Drug

Participants will get a single dose of [14C]GZR18 injection

Primary outcomes

  1. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).

  2. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces.

  3. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Peak Plasma Concentration (Cmax)

  4. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Area under the plasma concentration versus time curve (AUC)

  5. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Ratio of total radioactivity concentration in whole blood to plasma

  6. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Time-To-Peak(Tmax)

  7. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Mean Residence Time

  8. Primary Outcome Measure

    Time frame: Through study completion, an average of 1 year

    Half-Life Period(T1/2)

Secondary outcomes

  1. PK parameters of GZR18 and its metabolites (if applicable) in plasma

    Time frame: Through study completion, an average of 1 year

    Peak Plasma Concentration (Cmax)

  2. Safety Evaluation:Clinical safety evaluation during the study

    Time frame: Average of 1 year

    weight and height will be combined to report BMI in kg/m^2

  3. PK parameters of GZR18 and its metabolites (if applicable) in plasma

    Time frame: Through study completion, an average of 1 year

    Area under the plasma concentration versus time curve (AUC)

  4. PK parameters of GZR18 and its metabolites (if applicable) in plasma

    Time frame: through study completion, an average of 1 year

    Time-To-Peak(Tmax)

  5. PK parameters of GZR18 and its metabolites (if applicable) in plasma

    Time frame: through study completion, an average of 1 year

    Mean Residence Time

  6. PK parameters of GZR18 and its metabolites (if applicable) in plasma

    Time frame: through study completion, an average of 1 year

    Half-Life Period(T1/2)

  7. Safety Evaluation:Clinical safety evaluation during the study

    Time frame: Average of 1 year

    laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, stool analysis + occult blood and thyroid function)

Sponsors and collaborators

Lead sponsor

Gan & Lee Pharmaceuticals.

Industry

Registry information

Official study title

A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Nov 21, 2025

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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