Clinical trial NCT04920786: Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Lead sponsor: TrueBinding, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Day1-Day 75
measure: To determine the single-dose PK profile of TB006 in healthy adult subjects
timeFrame: Through day 75
measure: To determine the MTD of single doses of TB006 in healthy adult subjects
timeFrame: Through day 75
Secondary outcomes:
measure: Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: total clearance
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: volume of distribution
timeFrame: Through Day 75
measure: Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations
timeFrame: Through Day 75
measure: Safety and tolerability
timeFrame: Through Day 75
measure: Anti-TB006 antibodies
timeFrame: Through Day 75
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC (CNS)
state: California
Study officials:
affiliation: TrueBinding, Inc.
name: George Haig, PharmD
role: STUDY_DIRECTOR
affiliation: Collaborative Neuroscience Research
name: David Walling, MD
role: PRINCIPAL_INVESTIGATOR
References: