drugset / Trial / NCT07629310

To Evaluate the Safety of JL18008

NCT07629310 ↗

Phase 1 Completed 40 enrolled Jecho Biopharmaceuticals Co., Ltd.
RandomizedSequentialTriple-blindTreatment

Summary

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

Timeline

Start
2024-06-13
Primary completion
2025-08-05
Completion
2025-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject JL18008 Protein / enzyme biologic 1 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 5 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 10 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 20 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 40 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 70 ug/kg Intramuscular