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NCT01320761 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Injection Comfort of Two Formulations of ATX-101
A Phase 1 study of Healthy, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT01320761: Completed Phase 1 study of Healthy, sponsored by Kythera Biopharmaceuticals.
NCT01320761 is a Phase 1 study of Healthy that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320761, a Phase 1 study of Healthy, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.
Primary Outcome
The primary measure of comfort is the pain comparison scale between ATX-101-BA and ATX-101-BA-free at the time of injection using the pain comparison scale and the VAS pain rating scale.
Conditions Studied
Interventions
- DRUG ATX-101-BA-free
- DRUG ATX-101-BA
Study Locations (2)
Nebraska
- Joel Schlessinger, M.D. - Omaha
Texas
- Jeffrey M. Adelglass, M.D. - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
What the finished NCT01320761 record still lists
NCT01320761 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which ATX-101-BA-free is the first listed.
NCT01320761 reports a single indexed study location in Nebraska, Texas.
Frequently Asked Questions
What is clinical trial NCT01320761 about?
NCT01320761 is a clinical study titled "A Study to Assess Injection Comfort of Two Formulations of ATX-101". To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.
What is the current status of trial NCT01320761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants.
What conditions does trial NCT01320761 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01320761?
The interventions under investigation include: ATX-101-BA-free (DRUG), ATX-101-BA (DRUG).
Who is sponsoring clinical trial NCT01320761?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01320761 being conducted?
This trial has 2 study locations across Nebraska, 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 NCT01320761's enrollment target sits among peer trials
24 791st of 1090 higher than 254 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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