3 results
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
Part 1 (Dose Escalation) - to identify the recommended Phase 2 dose(s) and schedule(s) to be safe for JNJ-79635322. Part 2 (Dose Expansion) is to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s).
Stratum 1:To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu) results in a non inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte…