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

Alzheimer Disease Clinical Trial

— TB006SAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920786
• Other study ID #: TB006HV1101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2021
• Source: TrueBinding, Inc.
• Contact: Anna Cabral
• Phone: 714-891-0971
• Email: annecabral[@]cnstrial.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• TB006
TB006

Other:
• Sterile saline (Placebo)
Sterile saline

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Research, LLC (CNS)	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
TrueBinding, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29	PK:AUC D0-D29	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)	PK: AUC D0-8	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration	PK: Cmax	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs	PK: tmax	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life	PK: t(1/2)	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: total clearance	PK: CL	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: volume of distribution	PK: Vd	Through Day 75
Secondary	Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations	PK: CSF	Through Day 75
Secondary	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	Through Day 75
Secondary	Anti-TB006 antibodies	Number and rate of subjects who develop anti-TB006 antibodies	Through Day 75