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NOT YET RECRUITING
NCT07443228
PHASE1

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

Sponsor: Jecho Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-05-30

Completion Date

2030-12-31

Last Updated

2026-03-02

Healthy Volunteers

No

Conditions

Interventions

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.