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NCT03698305 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03698305: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03698305 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03698305, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
Primary Outcome
An AE is any untoward medical occurrence in a participants administered ASP5354, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be coded using MedDRA.
Interventions
- DRUG Placebo
- DRUG ASP5354
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-25 |
| Est. Completion | 2019-05-20 |
| Phase | Phase 1 |
What the finished NCT03698305 record still lists
NCT03698305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03698305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03698305 about?
NCT03698305 is a clinical study titled "A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product". The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
What is the current status of trial NCT03698305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-10-25. Estimated completion is 2019-05-20.
What interventions are being tested in trial NCT03698305?
The interventions under investigation include: Placebo (DRUG), ASP5354 (DRUG).
Who is sponsoring clinical trial NCT03698305?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03698305's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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