PainPhase 1NCT04067947
Phase 1 Pharmacokinetics, Safety, and Tolerability Study
A Phase 1 study testing XG005 in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- XG005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2019to 10 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official 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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- XG005, Placebos
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XG005Drug
XG005 Tablet
PlacebosDrug
Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| XG005 | Experimental | XG005 in 4 dose levels Receives: Drug: XG005 |
| Placebo | Placebo comparator | Placebo in all cohort Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event related to XG005
Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results
Measured: Day 1 to 7 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start8 Jul 2019
- Primary completion3 Dec 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xgene Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Xu, PHD, Study chair, Xgene Pharmaceutical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067947
- Sponsor's protocol ID
- XG005-02
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04067947
- Acronym / sponsor ID
- XG005-02
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Xgene Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XG005 | Experimental | Drug: XG005XG005 in 4 dose levels |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo in all cohort |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XG005XG005 Tablet | Drug | XG005 |
| PlacebosPlacebo Tablet | Drug | Placebo |
Primary outcome
Adverse Event related to XG005
Time frame: Day 1 to 7 days after last dose
Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Xu, PHD study chair
Xgene Pharmaceutical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XG005 in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event related to XG005 (time frame: Day 1 to 7 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.