Pharmacokinetics
BLOOD
Blood samples for pharmacokinetic analysis were collected from patients to assess the plasma concentrations of JMT101 following a single dose and multiple doses (steady state) of JMT101. Plasma samples were obtained from patients at pre-dose, immediately after the end of the dose (+2 min), at 4 h (±15 min), 8 h (±30 min), 24 h (±1 h), 48 ( ± 2 h), 96 h (±4 h), 168 h (±7 h), and 240 h (±12 h) after the 1st and 3rd dose, as well as once before the 2nd and 4th dose. Plasma concentrations of JMT101 were determined using validated analytical methods. The pharmacokinetic parameters of JMT101 were derived using non-compartmental methods and comprised maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the time-concentration curve (AUC), half-time (t½), Clearance (CL), etc.Blood samples for immunogenicity tests were collected within 30 min prior to the prespecified doses (the 1st, 2nd, 3rd and 5th dose) and at the last visit (30 ± 3 days after the last dose). Samples were first tested for anti-drug antibodies (ADA). Samples that were tested positive for ADA were further tested for neutralizing antibodies (Nabs).