NCT07443228

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

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of JL18008 Injection in HIV-Infected Immunological Non-Responders

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Jecho Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	JL18008	The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Timeline

• Start date: 2026-05-30
• Primary completion: 2029-12-20
• Completion: 2030-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study