A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Adults

What this Trial Is About

Researchers are conducting a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial to study GB18 in healthy adult participants aged 18 to 55 years. The study aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GB18, as well as its effects on body weight and the relationship between GB18 serum concentration and QTc interval. This phase 1 trial will enroll 36 healthy adults to gather important early information about GB18's properties and impact. Participants will be assigned to one of five dose groups receiving a single subcutaneous injection of GB18 at doses of 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg, or a matching placebo. Each dose group includes a small number of participants randomized in a 3:1 ratio to GB18 or placebo. The trial includes a sentinel dosing approach to first dose two participants before dosing the rest in each cohort. The Safety Review Committee will review safety and other data before dose escalation decisions. Participants will be admitted to a clinical research unit one day before dosing and receive the injection on Day 1. They will undergo safety assessments on Day 8 and may be discharged thereafter. Follow-up visits for blood sampling and evaluations including vital signs, ECG, and laboratory tests will occur on Days 10, 15, 29, 50, 71, 92, 106, and 127. The study will monitor adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity over approximately 18 weeks of follow-up to understand GB18's safety and biological effects in healthy adults.

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