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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD -Arm A) | Experimental | Up to 5 cohorts of subjects receiving sequentially ascending dose of TNB-738 or placebo are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified |
|
| Multiple Ascending Dose (MAD- Arm B) | Experimental | An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNB-738 | Drug | TNB-738 is an investigation drug. Other: Matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 21 weeks | |
| To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose. | 13 weeks | |
| To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose | 21 weeks | |
| Tmax (time for maximum serum concentration) for Single Ascending Dose | 13 weeks | |
| Tmax (time for maximum serum concentration) for Multiple Ascending Dose | 21 weeks | |
| Terminal elimination half-life (t1/2) for Single Ascending Dose | 13 weeks | |
| Terminal elimination half-life (t1/2) for Multiple Ascending Dose | 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738 | 13 weeks | |
| Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738 | 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Buelow, MD, PhD | TeneoFour Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd | Herston | Queensland | 4006 | Australia |
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Double blind
| TNB-738 | Drug | TNB-738 is an investigation drug. Other: Matching placebo |
|
| To determine CD38 enzyme activity following Single Ascending Dose | 13 weeks |
| To determine CD38 enzyme activity following Multiple Ascending Dose | 21 weeks |