Status:
COMPLETED
Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
Lead Sponsor:
TrueBinding, Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 treat...
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 un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04920786
Start Date
June 1 2021
End Date
May 3 2022
Last Update
December 9 2024
Active Locations (1)
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1
Collaborative Neuroscience Research, LLC (CNS)
Long Beach, California, United States, 90806