Alzheimer DiseasePhase 1TB006SADNCT04920786
Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
A Phase 1 study testing TB006 in people with Alzheimer Disease, run by TrueBinding, Inc. at 1 site in United States.
Trial summary
This is a single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TB006, a monoclonal antibody that will be studied as a disease modifying treatment for Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TB006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 3 May 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, male or female 18-55 at the time of informed consent
- In good health as determined by the principal investigator
- Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive).
- Chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: Must have been born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview; Must have lived no more than 10 years outside of China; Must not have changed their lifestyle or habits significantly, including diet, since leaving China.
Who cannot join
- Any current history of clinically significant disease in the opinion of the investigator or receiving maintenance medications on a daily basis.
- Any active or unstable clinically significant medical or psychiatric condition as judged by the investigator.
- Smokes cigarettes or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to screening.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 20 units for males or > 16 units for females. One unit is equivalent to 8 glasses of alcohol: a half pint (∼240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research, LLC (CNS)
Long Beach, California, 90806
About this study
Official title: A Phase 1 Double-blind, Randomized, Single Dose, Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
This is a single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TB006, a monoclonal antibody that will be studied as a disease modifying treatment for Alzheimer's disease.
Read the detailed description
The TB006 nonclinical pharmacology program establishes its potential as a therapeutic agent for AD. Overall, the data suggest the potential for beneficial therapeutic effects of TB006 in addressing underlying pathology and ameliorating the course of AD. The preclinical safety profile of TB006 further supports the clinical investigation of TB006. This is a Phase 1 SAD study in healthy adult subjects. The study will evaluate the safety, tolerability, and PK of single doses of TB006, administered as an IV infusion over 1 hour.
- Conditions
- Alzheimer Disease
- Being tested
- TB006, Sterile saline (Placebo)
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB006Drug
TB006
Sterile saline (Placebo)Other
Sterile saline
| Study group | Role | What they receive |
|---|---|---|
| TB006 70 mg - 5000 mg IV | Experimental | TB006 infused intravenously over 1 hour Receives: Drug: TB006 |
| Placebo | Placebo comparator | 0.9% normal saline infused intravenously over 1 hour Receives: Other: Sterile saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo
To measure the incidence of AEs and SAEs, clinical laboratory parameters, and vital signs until Day 75 after dosing.
Measured: Day1-Day 75
To determine the single-dose PK profile of TB006 in healthy adult subjects
PK parameters derived by noncompartmental analysis using the TB006 plasma concentration-time data
Measured: Through day 75
To determine the MTD of single doses of TB006 in healthy adult subjects
Dose-response relationship of AEs and SAEs, and other safety outcomes
Measured: Through day 75
Secondary outcomes (10)
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
PK:AUC D0-D29
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
PK: AUC D0-∞
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
PK: Cmax
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
PK: tmax
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
PK: t(1/2)
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
PK: CL
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
PK: Vd
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations
PK: CSF
Measured: Through Day 75
Safety and tolerability
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo in non-Chinese healthy and Chinese healthy subjects
Measured: Through Day 75
Anti-TB006 antibodies
Number and rate of subjects who develop anti-TB006 antibodies
Measured: Through Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Sequential
- Model description
- Six dose groups are planned: 5 dose levels of TB006 in healthy subjects and 1 ethno-bridging group in healthy subjects of Chinese descent.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrueBinding, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Haig, PharmD, Study director, TrueBinding, Inc.David Walling, MD, Principal investigator, Collaborative Neuroscience Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920786
- Sponsor's protocol ID
- TB006HV1101
- Acronym
- TB006SAD
- Status last verified
- Feb 2023
- First submitted
- 18 May 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Randomized, Single Dose, Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04920786
- Acronym / sponsor ID
- TB006SAD / TB006HV1101
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TrueBinding, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 10 Jun 2021 (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 single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TB006, a monoclonal antibody that will be studied as a disease modifying treatment for Alzheimer's disease.
Detailed description
The TB006 nonclinical pharmacology program establishes its potential as a therapeutic agent for AD. Overall, the data suggest the potential for beneficial therapeutic effects of TB006 in addressing underlying pathology and ameliorating the course of AD. The preclinical safety profile of TB006 further supports the clinical investigation of TB006. This is a Phase 1 SAD study in healthy adult subjects. The study will evaluate the safety, tolerability, and PK of single doses of TB006, administered as an IV infusion over 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Six dose groups are planned: 5 dose levels of TB006 in healthy subjects and 1 ethno-bridging group in healthy subjects of Chinese descent.
| Arm | Type | Receives |
|---|---|---|
| TB006 70 mg - 5000 mg IV | Experimental | Drug: TB006TB006 infused intravenously over 1 hour |
| Placebo | Placebo comparator | Other: Sterile saline (Placebo)0.9% normal saline infused intravenously over 1 hour |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers, male or female 18-55 at the time of informed consent
- In good health as determined by the principal investigator
- Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive).
- Chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: Must have been born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview; Must have lived no more than 10 years outside of China; Must not have changed their lifestyle or habits significantly, including diet, since leaving China.
Key exclusion criteria (4 listed)
- Any current history of clinically significant disease in the opinion of the investigator or receiving maintenance medications on a daily basis.
- Any active or unstable clinically significant medical or psychiatric condition as judged by the investigator.
- Smokes cigarettes or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to screening.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 20 units for males or > 16 units for females. One unit is equivalent to 8 glasses of alcohol: a half pint (∼240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
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 |
|---|---|---|
| TB006TB006 | Drug | TB006 70 mg - 5000 mg IV |
| Sterile saline (Placebo)Sterile saline | Other | Placebo |
Primary outcome
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo
Time frame: Day1-Day 75
To measure the incidence of AEs and SAEs, clinical laboratory parameters, and vital signs until Day 75 after dosing.
To determine the single-dose PK profile of TB006 in healthy adult subjects
Time frame: Through day 75
PK parameters derived by noncompartmental analysis using the TB006 plasma concentration-time data
To determine the MTD of single doses of TB006 in healthy adult subjects
Time frame: Through day 75
Dose-response relationship of AEs and SAEs, and other safety outcomes
10 secondary outcomes
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations
Time frame: Through Day 75
Safety and tolerability
Time frame: Through Day 75
Anti-TB006 antibodies
Time frame: Through Day 75
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 9 Dec 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.
George Haig, PharmD study director
TrueBinding, Inc.
David Walling, MD principal investigator
Collaborative Neuroscience Research
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 TB006 in people with Alzheimer Disease, run by TrueBinding, Inc. at 1 site in United States.
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 4 inclusion and 4 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 9 Dec 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 United States. 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. Some participants in this study may receive a placebo. 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?
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo (time frame: Day1-Day 75). The study lists 3 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 9 Dec 2024.