The Study of [14C] GZR18

Gan & Lee Pharmaceuticals.

Status and phase: Completed; Phase 1

Conditions: Obese; Overweight; Obesity

Treatments: Drug: GZR18 injection、[14C]GZR18 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07119450

GZR18-BWM-105

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Chinese adult male subjects aged 18-55 (inclusive);
3. Body weight ≥ 50 kg;
4. Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);
5. 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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Difficulty in blood collection or intolerance to venipuncture for blood collection.
7. 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.
8. Those who are not eligible for the study for other reasons as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

GZR18 injection、[14C]GZR18 injection

Experimental group

Treatment:

Drug: GZR18 injection、[14C]GZR18 injection