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NCT01779505 · ClinicalTrials.gov registry record · Phase 1
A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults
A Phase 1 study of Healthy Volunteers, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01779505: Completed Phase 1 study of Healthy Volunteers, sponsored by Gilead Sciences.
NCT01779505 is a Phase 1 study of Healthy Volunteers that has completed, run by Gilead Sciences. The registered enrollment target is 60 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01779505, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in various doses and dosing regimens in healthy adults at one center in the US. Subjects will be enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to achieve 48 evaluable subjects enrolled), with study completion in 9-12 months.
Primary Outcome
Frequency of serious adverse events Frequency and severity of common non-serious adverse events Frequency of discontinuations of therapy due to adverse events Common laboratory assessments (chemistry, hematology, urinalysis) Dose Limiting Toxicities
Conditions Studied
Interventions
- BIOLOGICAL GS-4774
Study Locations (1)
Arizona
- Celerion - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01779505 record still lists
NCT01779505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which GS-4774 is the first listed.
NCT01779505 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01779505 about?
NCT01779505 is a clinical study titled "A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults". This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in various doses and dosing regimens in healthy adults at one center in the US. Subjects will be enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing regimen cohorts. There...
What is the current status of trial NCT01779505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2013-01. Estimated completion is 2013-08.
What conditions does trial NCT01779505 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01779505?
The interventions under investigation include: GS-4774 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01779505?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01779505 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01779505's enrollment target sits among peer trials
60 109th of 283 higher than 163 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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