TB006 for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alzheimer's DiseaseTB006 - Drug
Eligibility
18 - 55
All Sexes
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Study Summary

This trial will study the safety and effectiveness of a new Alzheimer's drug.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Day1-Day 75

Day1-Day 75
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo
Through Day 75
Anti-TB006 antibodies
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
Cerebrospinal Fluid
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
Pharmacokinetic (PK) profile/parameters: total clearance
Pharmacokinetic (PK) profile/parameters: volume of distribution
Safety and tolerability
Through day 75
To determine the MTD of single doses of TB006 in healthy adult subjects
To determine the single-dose PK profile of TB006 in healthy adult subjects

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

TB006 70 mg - 5000 mg IV
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: TB006 · Has Placebo Group · Phase 1

TB006 70 mg - 5000 mg IV
Drug
Experimental Group · 1 Intervention: TB006 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Sterile saline (Placebo) · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day1-day 75

Who is running the clinical trial?

TrueBinding, Inc.Lead Sponsor
4 Previous Clinical Trials
440 Total Patients Enrolled
David Walling, MDPrincipal InvestigatorCollaborative Neuroscience Research
1 Previous Clinical Trials
65 Total Patients Enrolled
George Haig, PharmDStudy DirectorTrueBinding, Inc.
5 Previous Clinical Trials
1,278 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 3 Total Inclusion Criteria

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