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ARCT-810 · 3 trials · 3 indications
Safety and tolerability of ARCT-810 assessed by incidence, severity, and dose-relationship of AEs
Safety and tolerability of ARCT-810 assessed by determining the incidence, severity and dose-relationship of AEs by dose
| Arm | Type | Description |
|---|---|---|
| ARCT-810 | EXPERIMENTAL | Participants will receive up to 5 IV infusions of ARCT-810 administered at 14-day intervals. |
| Placebo | PLACEBO_COMPARATOR | Single doses of 0.9% Saline administered intravenously |
| Name | Type | Description |
|---|---|---|
| ARCT-810 | BIOLOGICAL | ARCT-810 is an investigational medicinal product comprising Ornithine Transcarbamylase (OTC) messenger RNA (mRNA) formulated in a lipid nanoparticle (LNP). |
| Placebo | OTHER | The placebo for this study is 0.9% sterile saline. |
Inclusion Criteria: 1. Willingness and ability to comply with all the protocol requirements, complete all study visits and sign informed consent. 2. Males and Females aged ≥12 years, at Screening. 3. Documented clinical diagnosis of OTC deficiency. 4. History of symptomatic hyperammonemia or elevat...
ARCT-810 is an investigational drug being developed for the treatment of Ornithine Transcarbamylase Deficiency (OTC Deficiency), a rare genetic disorder. It is currently in Phase 2 clinical development for this condition.
ARCT-810 is a monoclonal antibody being developed by Arcturus Therapeutics. The specific molecular target of ARCT-810 has not been disclosed in the available clinical trial information.
ARCT-810 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARCT.
ARCT-810 is currently in Phase 2 clinical development. It has completed two Phase 1 trials and is now being evaluated in a Phase 2 study for Ornithine Transcarbamylase Deficiency.
ARCT-810 has been studied in three clinical trials. Two Phase 1 trials (NCT04416126 and NCT04442347) are completed, and one Phase 2 trial (NCT06488313) is currently recruiting participants with OTC Deficiency.
ARCT-810 is not known by any alternative names. It is a distinct investigational drug being developed by Arcturus Therapeutics for the treatment of Ornithine Transcarbamylase Deficiency.