Pharmacokinetics
SAD
In SAD part, CSummary of derived pharmacokinetic parameters following single dose administration of OCS-05 (i.v. infusion) to healthy male and female subjects.Summary of derived pharmacokinetic parameters following single dose administration of OCS-05 (i.v. infusion) to healthy subjects as means (SD).C(ng/mL)54.3(20.7)222(48.5)474(38.5)828((98.7)2150(231)2750(259)3470(833)T(h)1.50(0.31)2.00(0.42)1.55(0.25)2.00(0.21)1.50(0.45)1.75(0.28)1.75(0.41)AUC(h*ng/mL)113(39.4)500(133.8)1110(108.3)1910(222)4960(625)6160(567)7930(2319)NC(NA)528(141.2)1110(75)1910(241)5150(745)6550(682)8430(2430)AUC(%)NC(NA)1.03(0.54)1.35(0.54)1.59(0.21)1.76(0.39)1.41(0.74)1.56(0.33)k(1/h)NC(NA)0.207(0.12)0.0893(0.02)0.0900(0.01)0.0865(0.02)0.0842(0.04)0.101(0.01)T½(h)NC(NA)3.35(2.96)7.77(2.72)7.71(1.13)8.01(1.43)8.23(4.59)6.84(0.58)Vz(mL)NC(NA)120,000(75,613)298,000(92,232)320,000(57,952)298,000(96,562)280,000(183,194)259,000(75,183)CL(mL/h)NC(NA)24,900(3989.7)26,600(3074)28,800(2519)25,800(4583)23,600(2020)26,300(6505)In the MAD part, CSummary of Derived Pharmacokinetic Parameters Following Multiple Dose Administration of OCS-05 (I.V. Infusion) to Healthy Male and female Subjects.Summary of derived pharmacokinetic parameters following multiple dose administration of OCS-05 (i.v. infusion) to healthy subjects by Day 5 as means (SD).In order to account for a subject who received an incorrect dose (2.85 mg/kg instead of 2.4 mg/kg), due to the administered dose being based on an incorrect weight of 77.1 kg (correct weight 65.0 kg), the PK analysis was also conducted excluding this subject using the supplementary PK set. The analysis of the supplementary PK set gave the same results as those described for the PK set above (data not shown).