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NCT02041715 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
A Phase 1 study, sponsored by Arbutus Biopharma Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02041715: Clinical Trial Phase 1 study, sponsored by Arbutus Biopharma Corporation.
NCT02041715 is a Phase 1 study that was terminated before completion, run by Arbutus Biopharma Corporation. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02041715, a Phase 1 study, was terminated before completion, sponsored by Arbutus Biopharma Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.
Primary Outcome
Subjects will be monitored for treatment-emergent and dose-limiting toxicity (DLT). If there are any adverse events (changes from baseline in laboratory parameters, vitals and/or infusion reactions) during these monitoring periods, the Independent Safety Committee, will discuss the dosing of the remaining subjects. Before proceeding to the next dose cohort, the Independent Safety Committee will evaluate whether dose escalation will be permitted based on demonstration of adequate safety and tole
Interventions
- DRUG Placebo
- DRUG TKM-100802 for Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
Why NCT02041715 stopped before completion
NCT02041715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02041715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02041715 about?
NCT02041715 is a clinical study titled "Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802". Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.
What is the current status of trial NCT02041715?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2014-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02041715?
The interventions under investigation include: Placebo (DRUG), TKM-100802 for Injection (DRUG).
Who is sponsoring clinical trial NCT02041715?
This trial is sponsored by Arbutus Biopharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02041715's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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