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NCT05132907 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein
A Phase 1 study, sponsored by HDT Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT05132907 is a Phase 1 study that has completed, run by HDT Bio. The registered enrollment target is 48 participants.
The verdict
NCT05132907, a Phase 1 study, has completed, sponsored by HDT Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.
Interventions
- BIOLOGICAL HDT-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05132907
The ClinicalTrials.gov registry entry for NCT05132907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HDT Bio, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HDT-301 is the first listed.
NCT05132907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05132907 about?
NCT05132907 is a clinical study titled "Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein". This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and ...
What is the current status of trial NCT05132907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-01-24. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT05132907?
The interventions under investigation include: HDT-301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05132907?
This trial is sponsored by HDT Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
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