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Clinical trials
catalyst calendar across sponsors →Studies where ARCT is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
13 interventional · 4 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic FibrosisNCT06747858Incidence, severity and dose relationship of adverse eventsNon-randomized · Open-label · Treatment | Phase 2 | Recruiting | Biological: ARCT-032 | Cystic Fibrosis, CFTR Gene Mutation | 33 | Jun 2027 | ≤ 315 d | 2026-05-08 |
| A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCDNCT06488313Incidence, severity and dose-relationship of adverse events (AEs)Open-label · Treatment | Phase 2 | Recruiting | Biological: ARCT-810 | OTC Deficiency, Ornithine Transcarbamylase Deficiency, OTCD | 9 | 2026-06-01 | — | 2025-03-17 |
| Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in AdultsNCT06602531Percentage of participants reporting local Adverse EventsRandomized · Quadruple-masked · PreventionInformed Consent Form ↗ | Phase 1 | Completed | Biological: ARCT-2304, Control vaccine (licensed seasonal influenza vaccine) younger adults, Control vaccine (licensed seasonal influenza vaccine) older adults · Other: Placebo Vaccine | Influenza, Human | 212 | 2025-06-13actual | — | 2026-04-03 |
| Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810NCT05526066Incidence, severity and dose-relationship of adverse events (AEs)Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: The study was terminated after the completion of Cohort 1 (0.3 mg/kg) due to slow enrollment in this placebo-controlled study. | Biological: ARCT-810 · Other: Placebo | Ornithine Transcarbamylase Deficiency, OTC Deficiency, OTCD | 8 | 2024-10-31actual | — | 2025-09-26 |
| Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in AdultsNCT06279871results2025-12-12Groups 2a and 2b and ARCT-154-J01 Historical Control: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Titers Against Omicron XBB.1.5 Subvariant at Day 29Randomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: ARCT-2303, Influenza vaccine, Influenza vaccine, adjuvanted · Other: Placebo | COVID-19 | 1,514 | 2024-10-09actual | — | 2025-12-12 |
| Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in AdultsNCT06125691Percentage of participants reporting local Adverse EventsRandomized · Quadruple-masked · Prevention | Phase 1 | Completed | Biological: ARCT-2138, Licensed Quadrivalent Vaccine for younger adults, Licensed Quadrivalent Vaccine for older adults | Influenza, Human | 139 | 2024-08-10actual | — | 2025-10-03 |
| Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.NCT05712538Incidence, severity and dose-relationship of AEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: ARCT-032 · Other: Placebo | Cystic Fibrosis | 39 | 2024-07-29actual | — | 2024-11-13 |
| A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy AdultsNCT05037097results2025-10-15Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: ARCT-165, ARCT-154, ARCT-021 | COVID-19, SARS-CoV-2 Infection, Corona Virus Infection | 72 | 2023-12-19actual | — | 2025-10-15 |
| Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase DeficiencyNCT04442347Incidence, severity and dose-relationship of adverse events (AEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Biological: ARCT-810 · Other: Placebo | Ornithine Transcarbamylase Deficiency | 16 | 2023-08-30actual | — | 2024-08-02 |
| A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy AdultsNCT04668339results2025-05-15Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming VaccinationRandomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: A decision was made to terminate the study for operational/business reasons. The study was not terminated for reasons of safety or immunogenicity. | Biological: ARCT-021 single dose priming, ARCT-021 two lower dose priming, ARCT-021 two higher dose priming, Placebo (two doses), priming, Randomized booster, Placebo booster | Covid19, SARS-CoV Infection, Corona Virus Infection | 581 | 2022-03-01actual | — | 2025-05-15 |
| Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021NCT04728347results2024-12-30Number of Participants With Solicited Local and Systemic Adverse EventsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: A decision was made to terminate the study for operational/business reasons. This study was not terminated for reasons of safety or immunogenicity. | Biological: ARCT-021 | SARS-CoV-2 | 65 | 2021-12-28actual | — | 2024-12-30 |
| Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult SubjectsNCT04480957Incidence, severity and dose-relationship of AEsRandomized · Double-masked · Treatment | Phase 1/2 | Completed | Biological: ARCT-021 Dose 1, ARCT-021 Dose 2, ARCT-021 Dose 3, ARCT-021 Dose 4, ARCT-021 Dose Regimen 1, ARCT-021 Dose Regimen 2 · Other: Placebo | SARS-CoV-2 | 106 | 2021-01-29actual | — | 2021-08-18 |
| Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult SubjectsNCT04416126Incidence, severity and dose-relationship of AEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Biological: ARCT-810 · Other: Placebo | Ornithine Transcarbamylase Deficiency | 30 | 2020-12-09actual | — | 2023-11-08 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19