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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: TNB-738

• Registration Number: NCT05215912
• Lead Sponsor: TeneoFour Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Study Start: 2022-04-21
• Status Verified: 2023-02
• Primary Completion: 2023-05-04
• Study Completion: 2023-07-11
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Healthy male or female
2. Age 18 - 75
3. Body mass index (BMI) ranging between 18 and 35 kg/m2, inclusive
4. Female subjects of child-bearing potential must agree to use one of the study-approved effective contraceptive methods for the duration of the study
5. Male subjects must practice true abstinence or agree to use a condom while participating in the study through End of study (EOS)
6. If female, a negative serum pregnancy test at Screening and urinary pregnancy test at Day -1 is required
7. Able to read, understand, and provide signed informed consent
8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria

1. Subject has any significant medical condition that would prevent the subject from participating in the study.
2. Subject is pregnant or breastfeeding.
3. Subject is currently receiving treatment with a biologic agent.
4. Subject has a history of anaphylactic reactions to biologic agents.
5. Subject has been dosed with another investigational drug study within 60 days prior to study drug administration.
6. Subject has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require antibiotic administration.
7. Subject has evidence of COVID-19 infection and/or subject is deemed at risk for the coronavirus disease in the opinion of the investigator or the subject has participated in another clinical study involving treatment(s), which may increase such risk.
8. Subject has used any prescription (excluding hormonal birth control) drugs within 14 days or illicit drugs within 30 days, or 5 half-lives (whichever is longer), prior to study drug administration.
9. Subject has a positive urine drug test or alcohol breath test at screening.
10. Subject has donated or lost more than 1 unit of blood (500 mL) within 60 days or more than 1 unit of serum within 7 days before the study drug administration.
11. Subject is HIV, HBV, or HCV positive.
12. Subject has received a live virus vaccine within 4 weeks of dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (SAD -Arm A)	TNB-738	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)	TNB-738	An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
To determine CD38 enzyme activity following Single Ascending Dose	13 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738	21 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738	13 weeks
To determine CD38 enzyme activity following Multiple Ascending Dose	21 weeks

Trial Locations

Locations (1)

Q-Pharm Pty Ltd; 🇦🇺 Herston, Queensland, Australia