Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects (TB006SAD)

TrueBinding

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Other: Sterile saline (Placebo); Drug: TB006

Study type: Interventional

Funder types: Industry

Identifiers

NCT04920786

TB006HV1101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

TB006 70 mg - 5000 mg IV

Experimental group

Description:

TB006 infused intravenously over 1 hour

Treatment:

Drug: TB006

Placebo

Placebo Comparator group

Description:

0.9% normal saline infused intravenously over 1 hour

Treatment:

Other: Sterile saline (Placebo)