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This current study was conducted in healthy Chinese volunteers to evaluate its safety, tolerability pharmacokinetics and immunogenicity profiles of recombinant human interferon beta-1b (rIFN β-1b) by subcutaneous administration (SC).
The clinical study included four single-dose (SD) cohorts and one multiple-dose (MD) cohort. The single-dose part was designed as a double-blind, randomized, placebo-controlled, dose-escalation (4-16 MIU dose range) study. Eight participants enrolled in each single-dose cohort were allocated (3∶1) to receive either rIFN β-1b or placebo. The multiple-dose cohort was mainly designed to assess the pharmacokinetics and immunogenicity profile of rIFN β-1b, with 8 MIU dose for eight consecutive days in eight healthy volunteers. The blood concentration of rIFN β-1b and the titre of anti-drug antibody (ADA) were quantified by a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetic parameters were calculated using a non-atrioventricular model with the WinNonlin software. The safety monitoring was carried out across the trial.
All 40 healthy participants enrolled and completed the trial. In 4, 8, 12 MIU SD groups, the Cmax were (63.18±34.64)、(125.17±59.19) and (214.00±89.02) pg·mL-1, respectively; AUC0-t were (3 247.63±1 842.60)、(7 903.33±3 427.03) and (9 740.00±2 333.47) h·pg·mL-1, respectively; AUC0-∞ were (4 374.00±1 087.74)、(8 861.67±3 677.13) and (10 528.33±2 344.60) h·pg·mL-1, respectively. The mean Cmax of rIFN β-1b approximately increased linearly with dose-relationship in the SD group (4-12 MIU) and the mean AUC0-t and AUC0-∞ showed the similar treand. The median tmax ranged from 5 to 12 hours in the SD groups. The median tmax was 4 hours in the MD group and no increase of the titre level of anti-drug antibody was found. The elimination half-life (t1/2) was similar in all dose groups, approximately 50 hours. No serious adverse events occurred and all adverse events returned to normal or baseline level. The common adverse events were mainly influenza-like illness, injection site adverse reactions and fever, all of which were graded as mild (Grade 1) or moderate (Grade 2).
The rIFN β-1b showed safe and well-tolerated in single and multiple doses cohorts of this study. Systemic exposure of IFN β-1b increased with dose-relationship in the single-dose group. These findings support the necessity for further clinical studies.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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