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NCT01518881 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion
A Phase 1 study, sponsored by Arbutus Biopharma Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01518881: Clinical Trial Phase 1 study, sponsored by Arbutus Biopharma Corporation.
NCT01518881 is a Phase 1 study that was terminated before completion, run by Arbutus Biopharma Corporation. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01518881, a Phase 1 study, was terminated before completion, sponsored by Arbutus Biopharma Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study with additional multiple-ascending dose cohorts in healthy male and female volunteers.
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-100201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
Why NCT01518881 stopped before completion
NCT01518881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01518881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01518881 about?
NCT01518881 is a clinical study titled "Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion". This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study with additional multiple-ascending dose cohorts in healthy male and female volunteers.
What is the current status of trial NCT01518881?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-01. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01518881?
The interventions under investigation include: Placebo (DRUG), TKM-100201 (DRUG).
Who is sponsoring clinical trial NCT01518881?
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 NCT01518881's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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