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

Recruiting Phase 1 Interventional Study
Cancer Cachexia (CC) Cancer Cachexia Cancer Cachexia Syndrome
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd. · Research network
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About This Trial
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 followi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures, and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle co…
Contacts

Kangsheng Yang

400-888-9496

yangkangsheng@kexing.com

CONTACT