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Monoclonal Antibodies

TB006 for Alzheimer's Disease (TB006SAD Trial)

Phase 1
Waitlist Available
Led By David Walling, MD
Research Sponsored by TrueBinding, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1-day 75
Awards & highlights

TB006SAD Trial Summary

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

TB006SAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1-day 75
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1-day 75 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
Secondary outcome measures
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
+7 more

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498
33%
Urinary tract infection
17%
Proctitis
17%
Blood urea increased
17%
Blood creatinine increased
17%
Abdominal pain upper
17%
Dizziness
17%
Renal impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Placebo
Part 1: TB006 420 mg qw
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Part 2: TB006 1000 mg qw
Part 2: Placebo
Part 1: TB006 1000 mg qw

TB006SAD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TB006 70 mg - 5000 mg IVExperimental Treatment1 Intervention
TB006 infused intravenously over 1 hour
Group II: PlaceboPlacebo Group1 Intervention
0.9% normal saline infused intravenously over 1 hour
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TB006
2021
Completed Phase 2
~160

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TrueBinding, Inc.Lead Sponsor
5 Previous Clinical Trials
334 Total Patients Enrolled
George Haig, PharmDStudy DirectorTrueBinding, Inc.
5 Previous Clinical Trials
1,278 Total Patients Enrolled
David Walling, MDPrincipal InvestigatorCollaborative Neuroscience Research
1 Previous Clinical Trials
65 Total Patients Enrolled
~12 spots leftby Jun 2025
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