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

(TB006SAD Trial)

Overseen By Anna Cabral

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: TrueBinding, Inc.

Must not be taking: Maintenance medications

Disqualifiers: Significant disease, Smoking, Alcohol, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing TB006, a special protein, to see if it is safe and well-tolerated in healthy adults. TB006 aims to help treat Alzheimer's by changing harmful brain processes. T-006, a small-molecule compound derived from tetramethylpyrazine (TMP), has potential for the treatment of neurological diseases.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, as the trial excludes anyone receiving maintenance medications on a daily basis.

Research Team

George Haig, PharmD

Principal Investigator

TrueBinding, Inc.

David Walling, MD

Principal Investigator

Collaborative Neuroscience Research

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of TB006 or placebo administered as an IV infusion over 1 hour

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics, including adverse events and PK parameters, until Day 75

10 weeks

Multiple visits (in-person and/or virtual)

Treatment Details

Interventions

• Sterile saline (Placebo)
• TB006

Participant Groups

Group I: TB006 70 mg - 5000 mg IV Experimental Treatment 1 Intervention

TB006 infused intravenously over 1 hour

Group II: Placebo Placebo Group 1 Intervention

0.9% normal saline infused intravenously over 1 hour

Who Is Running the Clinical Trial?

TrueBinding, Inc.

Lead Sponsor

Trials

7

Recruited

440+