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Safety and Effects of TB006 in Healthy Adults

Start: June 1, 2021
End: January 1, 2023
Enrollment: 48

What Is This Study About?

This Phase 1 study will examine the safety and effects of TB006, a potential treatment for Alzheimer's disease in healthy adults, including individuals of Chinese descent. Participants will be randomly assigned to receive one dose of five possible concentrations (70 mg - 5000 mg) of TB006 or a placebo by IV infusion over one hour. Researchers will monitor participants for side effects for 75 days and also collect blood and spinal fluid samples at regular intervals to measure the levels of the drug in the body and immune system response.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: 55 Years

Must have:

All Participants:

  • Overall good physical health, based on study screening evaluation
  • Body weight of at least 110 pounds with a Body Mass Index of 18 to 30

Chinese Participants:

  • Born in China
  • Two Chinese biological parents and four Chinese grandparents
  • Lived outside of China for no more than 10 years
  • No significant changes in lifestyle or habits since leaving China

Must NOT have:

  • Diagnosis of any serious or unstable medical or psychiatric condition that could interfere with the study
  • Taking any medication that could interfere with study results
  • Smoking or use of other nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, inhalers) within three months before starting study
  • Heavy alcohol consumption within six months before starting study, defined as:
    • Males:  > 20 drinks per week
    • Females:  > 16 drinks per week

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Anna Cabral

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

California
Collaborative Neuroscience Research, LLC (CNS)
Long Beach, CA 90806
Recruiting
Anne Cabral

Who Sponsors This Study?

Lead: TrueBinding, Inc.

Source: ClinicalTrials.gov ID: NCT04920786