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NCT05074498 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
A Phase 1 study, sponsored by TrueBinding.
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
NCT05074498: Completed Phase 1 study, sponsored by TrueBinding.
NCT05074498 is a Phase 1 study that has completed, run by TrueBinding. The registered enrollment target is 154 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05074498, a Phase 1 study, has completed, sponsored by TrueBinding.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
Study Summary
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be conducted to determine the clinical efficacy of TB006 in participants with mild to severe Alzheimer's Disease.
Primary Outcome
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injur
Interventions
- DRUG Placebo
- DRUG TB006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2022-10-13 |
| Phase | Phase 1 |
What the finished NCT05074498 record still lists
NCT05074498 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05074498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05074498 about?
NCT05074498 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease". Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be condu...
What is the current status of trial NCT05074498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2021-10-08. Estimated completion is 2022-10-13.
What interventions are being tested in trial NCT05074498?
The interventions under investigation include: Placebo (DRUG), TB006 (DRUG).
Who is sponsoring clinical trial NCT05074498?
This trial is sponsored by TrueBinding, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05074498's enrollment target sits among peer trials
154 356th of 2000 higher than 1,643 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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