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

NCT04920786 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TB006HV1101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  Through day 75

Secondary Outcomes (10)

• Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life

  Through Day 75

Study Arms (2)

TB006 70 mg - 5000 mg IV

EXPERIMENTAL

TB006 infused intravenously over 1 hour

Drug: TB006

Placebo

PLACEBO COMPARATOR

0.9% normal saline infused intravenously over 1 hour

Other: Sterile saline (Placebo)

Interventions

TB006 DRUG

TB006

TB006 70 mg - 5000 mg IV

Sterile saline (Placebo) OTHER

Sterile saline

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TrueBinding, Inc.: lead

Study Sites (1)

Collaborative Neuroscience Research, LLC (CNS)

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

TB006

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• George Haig, PharmD

  TrueBinding, Inc.

  STUDY DIRECTOR

• David Walling, MD

  Collaborative Neuroscience Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: December 9, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)