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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05215912




Registration number
NCT05215912
Ethics application status
Date submitted
23/11/2021
Date registered
31/01/2022
Date last updated
20/03/2024

Titles & IDs
Public title
A Single and Multiple Dosing Study Targeting Biparatopic Antibody CD38 in Healthy Volunteers
Scientific title
A Phase 1, Double-blind, Single- and Multiple-ascending Dose Escalation Study of TNB-738, a Biparatopic Antibody Targeting CD38 in Healthy Volunteers
Secondary ID [1] 0 0
TNB-738
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TNB-738
Treatment: Drugs - TNB-738

Experimental: Single Ascending Dose (SAD -Arm A) - 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

Experimental: Multiple Ascending Dose (MAD- Arm B) - An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established.


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

Treatment: Drugs: TNB-738
TNB-738 is an investigation drug. Other: Matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
13 weeks
Primary outcome [2] 0 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
Timepoint [2] 0 0
21 weeks
Primary outcome [3] 0 0
To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.
Timepoint [3] 0 0
13 weeks
Primary outcome [4] 0 0
To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose
Timepoint [4] 0 0
21 weeks
Primary outcome [5] 0 0
Tmax (time for maximum serum concentration) for Single Ascending Dose
Timepoint [5] 0 0
13 weeks
Primary outcome [6] 0 0
Tmax (time for maximum serum concentration) for Multiple Ascending Dose
Timepoint [6] 0 0
21 weeks
Primary outcome [7] 0 0
Terminal elimination half-life (t1/2) for Single Ascending Dose
Timepoint [7] 0 0
13 weeks
Primary outcome [8] 0 0
Terminal elimination half-life (t1/2) for Multiple Ascending Dose
Timepoint [8] 0 0
21 weeks
Secondary outcome [1] 0 0
Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738
Timepoint [1] 0 0
13 weeks
Secondary outcome [2] 0 0
Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738
Timepoint [2] 0 0
21 weeks
Secondary outcome [3] 0 0
To determine CD38 enzyme activity following Single Ascending Dose
Timepoint [3] 0 0
13 weeks
Secondary outcome [4] 0 0
To determine CD38 enzyme activity following Multiple Ascending Dose
Timepoint [4] 0 0
21 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/07/2023
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TeneoFour Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.
Trial website
https://clinicaltrials.gov/study/NCT05215912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Buelow, MD, PhD
Address 0 0
TeneoFour Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05215912