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Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects

NCT ID: NCT04920786

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-05-03

Brief Summary

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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

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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

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Alzheimer Disease

Keywords

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Six dose groups are planned: 5 dose levels of TB006 in healthy subjects and 1 ethno-bridging group in healthy subjects of Chinese descent.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TB006 70 mg - 5000 mg IV

TB006 infused intravenously over 1 hour

Group Type EXPERIMENTAL

TB006

Intervention Type DRUG

TB006

Placebo

0.9% normal saline infused intravenously over 1 hour

Group Type PLACEBO_COMPARATOR

Sterile saline (Placebo)

Intervention Type OTHER

Sterile saline

Interventions

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TB006

TB006

Intervention Type DRUG

Sterile saline (Placebo)

Sterile saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TrueBinding, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Haig, PharmD

Role: STUDY_DIRECTOR

TrueBinding, Inc.

David Walling, MD

Role: PRINCIPAL_INVESTIGATOR

Collaborative Neuroscience Research

Locations

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Collaborative Neuroscience Research, LLC (CNS)

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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TB006HV1101

Identifier Type: -

Identifier Source: org_study_id