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Published on: September 2, 2014
Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers
R D Huhn1, E Radwanski, J Gallo
1Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, USA.
Insights
Recombinant human interleukin-10 (IL-10) effectively suppressed inflammatory cytokine production in healthy volunteers. Doses below 50 micrograms/kg showed infrequent adverse events, indicating a favorable safety profile for this immunomodulatory cytokine.
Area of Science:
- Immunology
- Pharmacology
- Clinical Trials
Background:
- Interleukin-10 (IL-10) is a key cytokine with immunosuppressive properties.
- IL-10 inhibits T-lymphocyte functions and monocyte-derived inflammatory cytokine production.
- Understanding the in vivo effects and safety of recombinant IL-10 is crucial for therapeutic development.
Purpose of the Study:
- To evaluate the safety, tolerability, and pharmacokinetic profile of single subcutaneous doses of recombinant human interleukin-10 (rhIL-10) in healthy volunteers.
- To assess the immunomodulatory effects of rhIL-10 on ex vivo cytokine production.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 54 healthy volunteers.
- Administration of single subcutaneous doses of rhIL-10 (1.0 to 50 micrograms/kg) or placebo.
- Monitoring of clinical adverse events, serum cytokine concentrations, and hematologic parameters.
- Ex vivo stimulation of whole blood with lipopolysaccharide to measure cytokine production.
Main Results:
- Clinical adverse events were infrequent at doses below 50 micrograms/kg, with mild flu-like symptoms reported.
- Serum IL-10 concentrations demonstrated a dose-related increase.
- Pharmacokinetic parameters showed a mean terminal-phase half-life of 2.7–4.5 hours and a volume of distribution of 0.70–1.35 L/kg.
- Significant suppression of interleukin-1 beta and tumor necrosis factor-alpha production was observed in ex vivo assays.
Conclusions:
- Single subcutaneous doses of rhIL-10 are generally well-tolerated in healthy volunteers at doses up to 25 micrograms/kg.
- rhIL-10 exhibits dose-dependent pharmacokinetics and potent in vivo immunomodulatory activity.
- These findings support the potential therapeutic utility of rhIL-10 in inflammatory conditions.
Abstract:
Interleukin-10 inhibits T-lymphocyte activation and proliferation and lipopolysaccharide-induced monocyte production of proinflammatory cytokines. Fifty-four healthy volunteers received single doses of recombinant human interleukin-10 (1.0, 2.5, 5.0, 10, 25, or 50 micrograms/kg) or placebo by subcutaneous injection (randomized double-blind assignment). Clinical adverse events were infrequent at doses below 50 micrograms/kg (five of six subjects had mild flu-like syndrome). Mean serum interleukin-10 concentrations were dose related. The mean terminal-phase half-life ranged from 2.7 to 4.5 hours, and the apparent volume of distribution ranged from 0.70 to 1.35 L/kg. Hematologic changes included transient mild to moderate increases of neutrophil counts, decreases of lymphocyte counts, and a delayed decrease of platelet counts. Recombinant human interleukin-10 significantly suppressed production of the proinflammatory cytokines interleukin-1 beta and tumor necrosis factor-alpha by whole blood stimulated ex vivo with Escherichia coli lipopolysaccharide.
