NCT01723241

Brief Summary

This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2012

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 12, 2016

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

November 5, 2012

Last Update Submit

January 9, 2016

Conditions

Healthy

Keywords

volunteers

Study Arms (2)

XAF5

EXPERIMENTAL
Drug: XAF5, concentration ADrug: XAF5, concentration BDrug: XAF5, concentration C

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

XAF5, concentration ADRUG
XAF5
XAF5, concentration BDRUG
XAF5
XAF5, concentration CDRUG
XAF5
PlaceboDRUG
Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Must understand and provide informed consent
  • Skin upon which a reaction would be visible
  • Body weight \>= 70 kg

You may not qualify if:

  • Any active skin disease
  • History of skin hypersensitivity
  • Clinically significant abnormality on physical exam, ECG, or laboratory tests
  • Positive test for HIV, Hepatitis B, or Hepatitis C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael S. Singer, MD, PhD

    Topokine Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 12, 2016

Record last verified: 2013-04