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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 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.

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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.

Conditions Studied

Healthy

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

FieldValue
Enrollment Target 24 participants
Phase Phase 1

Sponsor

Kythera Biopharmaceuticals

19 total trials

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What the Registry Record Tells You About NCT01320761

The ClinicalTrials.gov registry entry for NCT01320761 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Kythera Biopharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.