A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders

The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs). Based on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg/kg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation/follow-up period. The study drug will be administered by intramuscular injection.

NCT Number	NCT07579741
Lead Sponsor	Jecho Biopharmaceuticals Co., Ltd.
Conditions	HIV Infections
Enrollment	30 participants
Start Date	2026-05-26
Primary Completion	2027-02-12 (estimated)
Study Completion	2027-09-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-06