NCT04067947

Brief Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 pain

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

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

July 8, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

February 20, 2020

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

August 13, 2019

Last Update Submit

February 19, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Adverse Event related to XG005

    Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results

    Day 1 to 7 days after last dose

Study Arms (2)

XG005

EXPERIMENTAL

XG005 in 4 dose levels

Drug: XG005

Placebo

PLACEBO COMPARATOR

Placebo in all cohort

Drug: Placebos

Interventions

XG005DRUG

XG005 Tablet

XG005
PlacebosDRUG

Placebo Tablet

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females between 18 and 55 years of age
  • BMI 18.0 to 30.0 kg/m2
  • Non-pregnant, non-breastfeeding female subjects

You may not qualify if:

  • Unstable or severe illness
  • History of, or current treatment for, GI disease
  • Clinically significant history of medical condition associated with GI events
  • History of or current glucose intolerance or gestational diabetes
  • Lifetime history of suicidal behavior
  • Creatinine clearance \< 90 mL/min
  • Any elevation of liver function tests
  • Creatine kinase (CK) value of greater than 1.5 times the upper limit
  • Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
  • Positive Hepatitis B surface antigen, HCV, or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Feng Xu, PHD

    Xgene Pharmaceutical Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The Investigator or designee, study coordinator(s), subjects, the Sponsor study team and its representatives, will be blinded to the treatment assignment.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 28, 2019

Study Start

July 8, 2019

Primary Completion

December 3, 2019

Study Completion

February 10, 2020

Last Updated

February 20, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)