NCT05215912

A Single and Multiple Dosing Study Targeting Biparatopic Antibody CD38 in Healthy Volunteers

A Phase 1, Double-blind, Single- and Multiple-ascending Dose Escalation Study of TNB-738, a Biparatopic Antibody Targeting CD38 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: TeneoFour Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.

Detailed description

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	TNB-738	TNB-738 is an investigation drug. Other: Matching placebo
DRUG	TNB-738	TNB-738 is an investigation drug. Other: Matching placebo

Timeline

• Start date: 2022-04-21
• Primary completion: 2023-05-04
• Completion: 2023-07-11
• First posted: 2022-01-31
• Last updated: 2024-03-20

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study