Healthy VolunteerPhase 1NCT05215912
A Single and Multiple Dosing Study Targeting Biparatopic Antibody CD38 in Healthy Volunteers
A Phase 1 study testing TNB-738 in people with Healthy Volunteer, run by TeneoFour Inc. at 1 site in Australia.
Trial summary
This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TNB-738
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Apr 2022to 11 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.
Read the 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
- Being tested
- TNB-738
- Keywords
- CD38
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNB-738Drug
TNB-738 is an investigation drug. Other: Matching placebo
TNB-738Drug
TNB-738 is an investigation drug. Other: Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: TNB-738 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 21 weeks
To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.
Measured: 13 weeks
To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose
Measured: 21 weeks
Tmax (time for maximum serum concentration) for Single Ascending Dose
Measured: 13 weeks
Tmax (time for maximum serum concentration) for Multiple Ascending Dose
Measured: 21 weeks
Terminal elimination half-life (t1/2) for Single Ascending Dose
Measured: 13 weeks
Terminal elimination half-life (t1/2) for Multiple Ascending Dose
Measured: 21 weeks
Secondary outcomes (4)
Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738
Measured: 13 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738
Measured: 21 weeks
To determine CD38 enzyme activity following Single Ascending Dose
Measured: 13 weeks
To determine CD38 enzyme activity following Multiple Ascending Dose
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start21 Apr 2022
- Primary completion4 May 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- TeneoFour Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Ben Buelow, MD, PhD, Study director, TeneoFour Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215912
- Sponsor's protocol ID
- TNB-738
- Status last verified
- Feb 2023
- First submitted
- 23 Nov 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05215912
- Acronym / sponsor ID
- TNB-738
- Conditions
- Healthy Volunteer
- Keywords
- CD38
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TeneoFour Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD -Arm A) | Experimental | Drug: TNB-738Up 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) | Experimental | Drug: TNB-738An expansion cohort (upto 4 cohorts) will be enrolled after maximum tolerated dose or recommended phase 2 dose is established. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNB-738TNB-738 is an investigation drug. Other: Matching placebo | Drug | Single Ascending Dose (SAD -Arm A) |
| TNB-738TNB-738 is an investigation drug. Other: Matching placebo | Drug | Multiple Ascending Dose (MAD- Arm B) |
Primary outcome
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
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
To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.
Time frame: 13 weeks
To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose
Time frame: 21 weeks
Tmax (time for maximum serum concentration) for Single Ascending Dose
Time frame: 13 weeks
Tmax (time for maximum serum concentration) for Multiple Ascending Dose
Time frame: 21 weeks
Terminal elimination half-life (t1/2) for Single Ascending Dose
Time frame: 13 weeks
Terminal elimination half-life (t1/2) for Multiple Ascending Dose
Time frame: 21 weeks
4 secondary outcomes
Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738
Time frame: 13 weeks
Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738
Time frame: 21 weeks
To determine CD38 enzyme activity following Single Ascending Dose
Time frame: 13 weeks
To determine CD38 enzyme activity following Multiple Ascending Dose
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Buelow, MD, PhD study director
TeneoFour Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNB-738 in people with Healthy Volunteer, run by TeneoFour Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.