drugset
drugset / Trial / NCT07443228

Recombinant Human Interleukin-7 (JL18008) for the Treatment of HIV-Infected Immunological Non-Responders

NCT07443228 ↗

Phase 1 Not yet recruiting 52 enrolled Jecho Biopharmaceuticals Co., Ltd.
RandomizedSequentialDouble-blindTreatment

Summary

JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and determine the RED in HIV INRs. Phase Ib: A randomized, double-blind, placebo-controlled, dose expansion study to evaluate the safety of JL18008 Injection and determine the RP2D in HIV INRs. Phase II: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JL18008 Injection in HIV INRs.

Timeline

Start
2026-05-30
Primary completion
2029-12-20
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject JL18008 Protein / enzyme biologic 1 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 2 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 4 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 8 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 16 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 30 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 50 ug/kg Intramuscular
Subject JL18008 Protein / enzyme biologic 70 ug/kg Intramuscular

Indications

HIV infectious disease