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NCT04815551 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of AV-380 in Healthy Subjects
A Phase 1 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT04815551 is a Phase 1 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 51 participants.
The verdict
NCT04815551, a Phase 1 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
Interventions
- DRUG Placebo
- DRUG AV-380
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04815551
The ClinicalTrials.gov registry entry for NCT04815551 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04815551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04815551 about?
NCT04815551 is a clinical study titled "A Phase 1 Study of AV-380 in Healthy Subjects". This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bi...
What is the current status of trial NCT04815551?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2021-02-22. Estimated completion is 2022-01-14.
What interventions are being tested in trial NCT04815551?
The interventions under investigation include: Placebo (DRUG), AV-380 (DRUG).
Who is sponsoring clinical trial NCT04815551?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
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