Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACI-24 low dose · 1 trial · 1 indication
All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. The measure is expressed in Arbitrary Units per mL (AU/mL). AU/mL in a sample is obtained by back-calculation towards the standard curve.
| Arm | Type | Description |
|---|---|---|
| ACI-24 low dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| ACI-24 high dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| Placebo | PLACEBO_COMPARATOR | The placebo is ready-to-use solution for injection, administrated s.c. 7 times. |
| Name | Type | Description |
|---|---|---|
| ACI-24 low dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| ACI-24 high dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| Placebo | BIOLOGICAL | Placebo is a standard PBS sterile solution administrated via s.c. injection. |
Inclusion Criteria: * Males or females with Down Syndrome aged ≥25 to ≤45 years, with a cytogenetic diagnosis being either Trisomy 21 or Complete Unbalanced Translocation of the Chromosome 21. * Subjects and their study partner/legal representative in the opinion of the investigator able to underst...
ACI-24 low dose is an investigational monoclonal antibody being studied for use in adults with Down Syndrome. It is being evaluated as a potential treatment for this rare disease. The drug is currently in clinical development and has not been approved by regulatory authorities.
ACI-24 low dose is being developed by AC Immune SA, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACIU. The company is conducting clinical research to evaluate the safety and immunogenicity of this investigational therapy in adults with Down Syndrome.
ACI-24 low dose is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety, tolerability, and immunogenicity in adults with Down Syndrome.
ACI-24 low dose has been studied in one clinical trial, identified as NCT02738450. This Phase 1 trial, titled 'Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome,' has been completed. The study enrolled 20 participants in the United States, with a minimum age of 25 years.
ACI-24 low dose is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted it Fast Track designation, which is intended to facilitate development and expedite review of drugs that treat serious conditions and fill an unmet medical need.
ACI-24 low dose is described as a monoclonal antibody, though the completed clinical trial NCT02738450 refers to it as a vaccine. The study evaluated its safety, tolerability, and immunogenicity in adults with Down Syndrome. The drug is being developed by AC Immune SA for this rare disease indication.