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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT04920786

Run by

TrueBinding, Inc.

People needed

48

Starts

2021-06-01

Expected to finish

2022-05-03

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Collaborative Neuroscience Research, LLC (CNS) — Long Beach, California, United States

Full record on ClinicalTrials.gov

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