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To evaluate the safety and tolerance of a single administration versus multiple administrations of recombinant human parathyroid hormone 1-84 (PTH1-84) for injection in Chinese healthy volunteers, as well as to observe the pharmacokinetic characteristics in health individuals following drug administration.
A single center, open, single administration/multiple administration trial was designed. The healthy subjects were divided into four dose groups: 25, 50, 75 and 100 μg, in which the 25 μg dose group was only given at a single dose, and the other three dose groups continued to conduct continuous administration after a single dose. The physical signs of the subjects were recorded, and the biological samples were collected at the time specified in the scheme to calculate and analyze the pharmacokinetic parameters. The safety of different doses of recombinant PTH1-84 was evaluated by the pharmacokinetic parameters of healthy subjects and the occurrence of adverse reactions.
A total of 28 healthy subjects were included in the study, with 4 participants in the 25 μg dosage group and 8 participants in each of the remaining three groups. In the safety evaluation, no correlation between the incidence of adverse events and dosages was observed, and no serious adverse events occurred. The reported adverse reactions resolved favorably. The pharmacokinetic results indicate that recombinant human parathyroid hormone 1-84, within the dosage range of 50 to 100 μg, demonstrates a dose-dependent relationship for both AUC and Cmax following single and multiple administrations. This suggests a positive correlation between drug exposure and dosage.
PTH1-84 has good clinical safety and tolerance at the experimental dose.
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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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