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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04067947




Registration number
NCT04067947
Ethics application status
Date submitted
13/08/2019
Date registered
28/08/2019
Date last updated
20/02/2020

Titles & IDs
Public title
Phase 1 Pharmacokinetics, Safety, and Tolerability Study
Scientific title
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
Secondary ID [1] 0 0
XG005-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XG005
Treatment: Drugs - Placebos

Experimental: XG005 - XG005 in 4 dose levels

Placebo Comparator: Placebo - Placebo in all cohort


Treatment: Drugs: XG005
XG005 Tablet

Treatment: Drugs: Placebos
Placebo Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Event related to XG005
Timepoint [1] 0 0
Day 1 to 7 days after last dose

Eligibility
Key inclusion criteria
1. Healthy males or females between 18 and 55 years of age

2. BMI 18.0 to 30.0 kg/m2

3. Non-pregnant, non-breastfeeding female subjects
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unstable or severe illness

2. History of, or current treatment for, GI disease

3. Clinically significant history of medical condition associated with GI events

4. History of or current glucose intolerance or gestational diabetes

5. Lifetime history of suicidal behavior

6. Creatinine clearance < 90 mL/min

7. Any elevation of liver function tests

8. Creatine kinase (CK) value of greater than 1.5 times the upper limit

9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal

10. Positive Hepatitis B surface antigen, HCV, or HIV

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2020
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xgene Pharmaceutical Group
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04067947
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Feng Xu, PHD
Address 0 0
Xgene Pharmaceutical Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04067947