drugset / Trial / NCT06247345
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2. The study includes 2 parts: Part 1 (single ascending dose \[SAD\] and Part 2 (multiple ascending dose \[MAD\]).
Timeline
- Start
- 2024-02-06
- Primary completion
- 2026-01-07
- Completion
- 2026-01-07
Outcome
Outcome not reported
Stopped (Business): “Study discontinued due to sponsor transition and strategic decision not to continue the protocol.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADEL-Y01 | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Comparator | ADEL-Y01 | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | ADEL-Y01 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Comparator | ADEL-Y01 | Monoclonal antibody | 50 mg/kg | Intravenous |
| Comparator | ADEL-Y01 | Monoclonal antibody | 100 mg/kg | Intravenous |