MedTrace Logo

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants

NCT07237464 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-19

No results posted yet for this study

Summary

This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.

A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo.

The arms of this study include:

To evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants.

To characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants.

To characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants.

To evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.

Conditions

  • Cancer Cachexia (CC)
  • Cancer Cachexia
  • Cancer Cachexia Syndrome

Interventions

DRUG

GB18 injection

GB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts.

DRUG

Placebo

Placebo will be administered to participants at doses matching GB18.

Sponsors & Collaborators

  • Shenzhen Kexing Pharmaceutical Co., Ltd.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-01-20
Completion
2026-04-20
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237464 on ClinicalTrials.gov