drugset / Trial / NCT06575153
Phase 1 Study of ART5803 in Healthy Participants
RandomizedSequentialQuadruple-blindOther
Summary
The study is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ART5803 compared with placebo in healthy adult participants
Timeline
- Start
- 2024-09-19
- Primary completion
- 2025-09-11
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ART5803 | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | ART5803 | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | ART5803 | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Subject | ART5803 | Protein / enzyme biologic | 60 mg/kg | Intravenous |
| Subject | ART5803 | Protein / enzyme biologic | 100 mg/kg | Intravenous |