The Study of [14C] GZR18

NCT07119450 | Completed Phase 1

• 1 other identifier: GZR18-BWM-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Overweight; Obese; Obesity

Outcome Measures

Primary Outcomes (8)

• Primary Outcome Measure

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

  Through study completion, an average of 1 year

• Primary Outcome Measure

  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.

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Peak Plasma Concentration (Cmax)

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Area under the plasma concentration versus time curve (AUC)

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Ratio of total radioactivity concentration in whole blood to plasma

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Time-To-Peak(Tmax)

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Mean Residence Time

  Through study completion, an average of 1 year

• Primary Outcome Measure

  Half-Life Period（T1/2）

  Through study completion, an average of 1 year

Secondary Outcomes (7)

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

  Through study completion, an average of 1 year

• Safety Evaluation:Clinical safety evaluation during the study

  Average of 1 year

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

  Through study completion, an average of 1 year

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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

Study Arms (1)

GZR18 injection、[14C]GZR18 injection

EXPERIMENTAL

Drug: GZR18 injection、[14C]GZR18 injection

Interventions

GZR18 injection、[14C]GZR18 injection DRUG

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

GZR18 injection、[14C]GZR18 injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Study site 01

Beijing, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 13, 2025
• Study Start: May 7, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

CN (1)