A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD
Summary
This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's disease (AD).
Timeline
- Start
- 2021-06-21
- Primary completion
- 2023-06-12
- Completion
- 2023-06-12
Outcome
Met primary endpoint
release “ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of its first-in-human, randomized, double-blind, placebo-controlled study” halozyme.com ↗
release “Topline results from INTERCEPT-AD trial met primary and secondary objectives, demonstrating proof-of-mechanism for ACU193” acumenpharm.com ↗
release “INTERCEPT-AD trial which demonstrated that ACU193 was well-tolerated with a compelling overall safety profile, meeting the primary objective” acumenpharm.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sabirnetug | Monoclonal antibody | — | Intravenous |