This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.
TNB-738 is a fully human bispecific antibody used to inhibit human CD38 enzyme. The study will consist of 2 arms (A and B). The SAD arm (Arm A) of the study consists of sequential single dose escalation cohorts, whereas the MAD portion (Arm B) of the study consists of sequential dose escalation cohorts receiving study drug once every 4 weeks for 3 doses. In both Arm A and Arm B, subjects will be randomized to receive either TNB-738 or matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Q-Pharm Pty Ltd
Herston, Queensland, Australia
Safety and tolerability of TNB-738 by the incidence of treatment emergent adverse events in Single Ascending group. Adverse Events will be graded according to the NCI-CTCAE, version 5.0
Time frame: 13 weeks
Safety and tolerability of TNB-738 by the incidence of treatment emergent adverse events in Multiple Ascending group. Adverse Events will be graded according to the NCI-CTCAE, version 5.0
Time frame: 21 weeks
To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.
Time frame: 13 weeks
To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose
Time frame: 21 weeks
Tmax (time for maximum serum concentration) for Single Ascending Dose
Time frame: 13 weeks
Tmax (time for maximum serum concentration) for Multiple Ascending Dose
Time frame: 21 weeks
Terminal elimination half-life (t1/2) for Single Ascending Dose
Time frame: 13 weeks
Terminal elimination half-life (t1/2) for Multiple Ascending Dose
Time frame: 21 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738
Time frame: 13 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738
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Time frame: 21 weeks
To determine CD38 enzyme activity following Single Ascending Dose
Time frame: 13 weeks
To determine CD38 enzyme activity following Multiple Ascending Dose
Time frame: 21 weeks