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.
Age between 18 - 65 years old, male or female.
Body Mass Index (BMI) between 18 - 32 kg/m2, body weight ≥ 50 kg in male and ≥ 45 kg in female.
On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry.
Plasma HIV RNA < 50 copies/mL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are < 50 copies/mL).
Prior treatment with IL-7 or IL-2.
Allergy to JL18008 Injection components, e.g. HSA.
Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry.
Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases.
Sequential
JL18008
DrugThe 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.
8
Treatment groupsSee each treatment group below.
The safety of JL18008
Number of participants with any death.
The safety of JL18008
Number of participants with AEs and SAEs.
The safety of JL18008
Number of participants with discontinuation due to AEs.
To Evaluate the Pharmacokinetics of JL18008
Cmax
To Evaluate the Pharmacokinetics of JL18008
Tmax
To Evaluate the Pharmacokinetics of JL18008
AUC0-inf
To Evaluate the Pharmacokinetics of JL18008
t1/2
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