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NCT03047317 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of MABp1 in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT03047317: Completed Phase 1 study of Healthy, sponsored by Janssen Research & Development.
NCT03047317 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 6 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03047317, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.
Primary Outcome
Pharmacokinetics--blood levels of MABp1 antibody
Conditions Studied
Interventions
- BIOLOGICAL MABp1
Study Locations (1)
Texas
- XBiotech Investigative Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 1 |
What the finished NCT03047317 record still lists
NCT03047317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which MABp1 is the first listed.
NCT03047317 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03047317 about?
NCT03047317 is a clinical study titled "A Pharmacokinetic Study of MABp1 in Healthy Volunteers". This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 h...
What is the current status of trial NCT03047317?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-02-15. Estimated completion is 2017-03-31.
What conditions does trial NCT03047317 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03047317?
The interventions under investigation include: MABp1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03047317?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03047317 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03047317's enrollment target sits among peer trials
6 1075th of 1090 higher than 7 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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