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NCT05203692 · ClinicalTrials.gov registry record · Phase 1
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
A Phase 1 study of Systemic Lupus Erythematosus, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT05203692: Completed Phase 1 study of Systemic Lupus Erythematosus, sponsored by Daiichi Sankyo.
NCT05203692 is a Phase 1 study of Systemic Lupus Erythematosus that has completed, run by Daiichi Sankyo. The registered enrollment target is 80 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05203692, a Phase 1 study of Systemic Lupus Erythematosus, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
Primary Outcome
Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DS-7011a
Study Locations (2)
California
- Apex Clinical Research (Collaborative Neuroscience Research) - Long Beach
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2023-03-22 |
| Phase | Phase 1 |
What the finished NCT05203692 record still lists
NCT05203692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05203692 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT05203692 about?
NCT05203692 is a clinical study titled "A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects". This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
What is the current status of trial NCT05203692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2022-02-02. Estimated completion is 2023-03-22.
What conditions does trial NCT05203692 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT05203692?
The interventions under investigation include: Placebo (DRUG), DS-7011a (DRUG).
Who is sponsoring clinical trial NCT05203692?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05203692 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05203692's enrollment target sits among peer trials
80 61st of 99 higher than 38 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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