![]() ![]() At the highest doses tested, administration of NKTR-358 resulted in a 12–17-fold increase in CD25bright Tregs over baseline that was sustained for 20–30 days. Dose-dependent, selective, and sustained increases in percentages and absolute numbers of total CD4⁺ Tregs and CD25bright Tregs were observed, with no significant changes in conventional CD4⁺ and CD8⁺ T cells, and low-level increases in natural killer cells. PK data showed dose proportionality and prolonged exposure (mean half-life: 7.4–12.9 days). Most adverse events (AEs) were grade 1–2 injection-site reactions, with no treatment‐related serious or severe AEs, or deaths. ![]() ![]() There were eight ascending dose cohorts in the SAD study (0.3–28.0 μg/kg: n = 76 placebo: n = 24) and four in the MAD study (3–24.0 μg/kg: n = 36 placebo: n = 12). Primary objectives were safety and tolerability secondary objectives included pharmacokinetics (PK) and immune effects of NKTR-358 exploratory objectives included effects on SLE disease activity. Healthy volunteers and patients with systemic lupus erythematosus (SLE) received single- or multiple-dose (biweekly) NKTR-358 or placebo in two sequential, randomized, phase 1 studies (single ascending dose and multiple ascending dose ). To evaluate NKTR-358, a polyethylene glycol-interleukin-2 conjugate composition designed to selectively induce regulatory T cells (Tregs), in first-in-human studies. ![]()
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