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

NCT05215912 | Completed Phase 1 FDA Drug

• 1 other identifier: TNB-738
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

CD38

Outcome Measures

Primary Outcomes (8)

• 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

Secondary Outcomes (4)

• 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

• To determine CD38 enzyme activity following Single Ascending Dose

  13 weeks

• To determine CD38 enzyme activity following Multiple Ascending Dose

  21 weeks

Study Arms (2)

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

Drug: TNB-738

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.

Drug: TNB-738

Interventions

TNB-738 DRUG

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

Single Ascending Dose (SAD -Arm A)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TeneoFour Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

Study Officials

• Ben Buelow, MD, PhD

  TeneoFour Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 31, 2022
• Study Start: April 21, 2022
• Primary Completion: May 4, 2023
• Study Completion: July 11, 2023
• Last Updated: March 20, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)