Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-1758 · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Measured by amyloid positron emission tomography (PET)
Cmax of ABBV-1758
Tmax of ABBV-1758
Ctrough of ABBV-1758
AUCtau of ABBV-1758
Cav,ss of ABBV-1758
AUCtau of ABBV-1758
CL of ABBV-1758
CL/F of ABBV-1758
Vss of ABBV-1758
Vz of ABBV-1758
β of ABBV-1758
Terminal phase elimination half-life of ABBV-1758
T1/2,eff of ABBV-1758
| Arm | Type | Description |
|---|---|---|
| Stage A-ABBV-1758 Dose A | EXPERIMENTAL | Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W). |
| Placebo for ABBV-1758 Dose A | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose B | EXPERIMENTAL | Participants will receive ABBV-1758 dose B Q4W. |
| Placebo for ABBV-1758 Dose B | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose C | EXPERIMENTAL | Participants will receive ABBV-1758 dose C Q4W. |
| Placebo for ABBV-1758 Dose C | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose D | EXPERIMENTAL | Participants will receive ABBV-1758 dose D Q4W. |
| Placebo for ABBV-1758 Dose D | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage B- ABBV-1758 - Expanded Cohort 1 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758 - Expanded Cohort 1 | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage B- ABBV-1758- Expanded Cohort 2 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Expanded Cohort 2 | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758 - Japanese Cohort 1 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758 - Japanese Cohort 1 | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758- Japanese Cohort 2 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Japanese Cohort 2 | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758-Chinese Cohort | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Chinese Cohort | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-1758. |
| Name | Type | Description |
|---|---|---|
| ABBV-1758 | DRUG | Intravenous (IV) or Subcutaneous (SC) |
| Placebo for ABBV-1758 | DRUG | Intravenous (IV) or Subcutaneous (SC) |
Inclusion Criteria: * Participants meeting all the following criteria for Alzheimer's disease (AD): * In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that ...
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ABBV-1758 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied to assess its safety and effects in participants with Alzheimer's Disease.
ABBV-1758 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and effects of this investigational drug in patients with Alzheimer's Disease.
ABBV-1758 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety and effects in Alzheimer's Disease.
ABBV-1758 is being evaluated in a Phase 1 clinical trial with the identifier NCT07599670. This study is assessing the safety and effects of ABBV-1758 following subcutaneous or intravenous injections in participants with Alzheimer's Disease. The trial is recruiting 210 participants in the United States and China.
In the ongoing Phase 1 clinical trial, ABBV-1758 is administered via subcutaneous or intravenous injections. The study is designed to evaluate the safety and effects of the drug in participants with Alzheimer's Disease. The trial is randomized, double-blind, and placebo-controlled.
No alternative names for ABBV-1758 have been disclosed. The drug is identified solely by its development code ABBV-1758 in clinical trial records. It is an investigational small molecule being studied for Alzheimer's Disease and is not known to be marketed under any other name.