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

Primary Purpose

Healthy Volunteer

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

TNB-738

About this trial

This is an interventional treatment trial for Healthy Volunteer focused on measuring CD38

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Subject has any significant medical condition that would prevent the subject from participating in the study.
Subject is pregnant or breastfeeding.
Subject is currently receiving treatment with a biologic agent.
Subject has a history of anaphylactic reactions to biologic agents.
Subject has been dosed with another investigational drug study within 60 days prior to study drug administration.
Subject has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require antibiotic administration.
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.
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.
Subject has a positive urine drug test or alcohol breath test at screening.
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.
Subject is HIV, HBV, or HCV positive.
Subject has received a live virus vaccine within 4 weeks of dosing

Sites / Locations

Q-Pharm Pty LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single Ascending Dose (SAD -Arm A)

Multiple Ascending Dose (MAD- Arm B)

Arm Description

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

An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established.

Outcomes

Primary Outcome Measures

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

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

To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.

To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose

Tmax (time for maximum serum concentration) for Single Ascending Dose

Tmax (time for maximum serum concentration) for Multiple Ascending Dose

Terminal elimination half-life (t1/2) for Single Ascending Dose

Terminal elimination half-life (t1/2) for Multiple Ascending Dose

Secondary Outcome Measures

Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738

Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738

To determine CD38 enzyme activity following Single Ascending Dose

To determine CD38 enzyme activity following Multiple Ascending Dose

Full Information

NCT ID

NCT05215912

First Posted

November 23, 2021

Last Updated

February 15, 2023

Sponsor

TeneoFour Inc.

Collaborators

Novotech (Australia) Pty Limited

1. Study Identification

Unique Protocol Identification Number

NCT05215912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 7, 2022 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TeneoFour Inc.

Collaborators

Novotech (Australia) Pty Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteer

Keywords

CD38

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double blind

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Ascending Dose (SAD -Arm A)

Arm Type

Experimental

Arm Description

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

Arm Title

Multiple Ascending Dose (MAD- Arm B)

Arm Type

Experimental

Arm Description

An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established.

Intervention Type

Drug

Intervention Name(s)

TNB-738

Intervention Description

TNB-738 is an investigation drug. Other: Matching placebo

Intervention Type

Drug

Intervention Name(s)

TNB-738

Intervention Description

TNB-738 is an investigation drug. Other: Matching placebo

Primary Outcome Measure Information:

Title

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

Title

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

Title

To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.

Time Frame

13 weeks

Title

To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose

Time Frame

21 weeks

Title

Tmax (time for maximum serum concentration) for Single Ascending Dose

Time Frame

13 weeks

Title

Tmax (time for maximum serum concentration) for Multiple Ascending Dose

Time Frame

21 weeks

Title

Terminal elimination half-life (t1/2) for Single Ascending Dose

Time Frame

13 weeks

Title

Terminal elimination half-life (t1/2) for Multiple Ascending Dose

Time Frame

21 weeks

Secondary Outcome Measure Information:

Title

Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738

Time Frame

13 weeks

Title

Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738

Time Frame

21 weeks

Title

To determine CD38 enzyme activity following Single Ascending Dose

Time Frame

13 weeks

Title

To determine CD38 enzyme activity following Multiple Ascending Dose

Time Frame

21 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or female Age 18 - 75 Body mass index (BMI) ranging between 18 and 35 kg/m2, inclusive Female subjects of child-bearing potential must agree to use one of the study-approved effective contraceptive methods for the duration of the study Male subjects must practice true abstinence or agree to use a condom while participating in the study through End of study (EOS) If female, a negative serum pregnancy test at Screening and urinary pregnancy test at Day -1 is required Able to read, understand, and provide signed informed consent Able to communicate adequately with the investigator and to comply with the requirements for the entire study. Exclusion Criteria: Subject has any significant medical condition that would prevent the subject from participating in the study. Subject is pregnant or breastfeeding. Subject is currently receiving treatment with a biologic agent. Subject has a history of anaphylactic reactions to biologic agents. Subject has been dosed with another investigational drug study within 60 days prior to study drug administration. Subject has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require antibiotic administration. 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. 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. Subject has a positive urine drug test or alcohol breath test at screening. 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. Subject is HIV, HBV, or HCV positive. Subject has received a live virus vaccine within 4 weeks of dosing

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ben Buelow, MD, PhD

Phone

(650) 955-6865

studydirector@ancorabiotech.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ben Buelow, MD, PhD

Organizational Affiliation

TeneoFour Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Q-Pharm Pty Ltd

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Friend

Phone

+61 7 3707 2700

r.friend@nucleusnetwork.com.au

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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