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NCT01115920 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
A Phase 1 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01115920: Completed Phase 1 study, sponsored by Stealth BioTherapeutics.
NCT01115920 is a Phase 1 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01115920, a Phase 1 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.
Primary Outcome
Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.
Interventions
- DRUG MTP-131 (Bendavia™)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01115920 record still lists
NCT01115920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which MTP-131 (Bendavia™) is the first listed.
NCT01115920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01115920 about?
NCT01115920 is a clinical study titled "Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults". This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.
What is the current status of trial NCT01115920?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01115920?
The interventions under investigation include: MTP-131 (Bendavia™) (DRUG).
Who is sponsoring clinical trial NCT01115920?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01115920's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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