Phase 1 Pharmacokinetics, Safety, and Tolerability Study | NCT04067947

Studies
Phase 1 Pharmacokinetics, Safety, and Tolerability Study

NCT04067947

Sponsor

Xgene Pharmaceutical Group

Status

Completed

Last Update Posted

Feb 20, 2020Actual

Enrollment

64Actual

Phase

Phase 1

Conditions

Pain

Interventions

XG005
Placebos

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2019Actual

Primary Completion Date

Dec 3, 2019Actual

Completion Date

Feb 10, 2020Actual

First Submitted Date

Aug 13, 2019

First Submission Date that Met QC Criteria

Aug 21, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XG005	Experimental	XG005 in 4 dose levels	Drug: XG005
Placebo	Placebo Comparator	Placebo in all cohort	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XG005	Drug	XG005 Tablet	XG005
Placebos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Feng Xu, PHD	Xgene Pharmaceutical Group	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linear Clinical Research Ltd		Nedlands	Western Australia	6009	Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

The Investigator or designee, study coordinator(s), subjects, the Sponsor study team and its representatives, will be blinded to the treatment assignment.

Who Masked

ParticipantCare ProviderInvestigator