HealthyPhase 1NCT05727189
A Study of Idazoxan in Healthy Participants
A Phase 1 study testing TR-01-XRR (1), TR-01-XRR (2) and TR-01-XRR (3) in people with Healthy, run by Terran Biosciences Australia Pty Ltd at 2 sites in Australia.
Trial summary
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TR-01-XRR (1), TR-01-XRR (2) and TR-01-XRR (3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesAustralia
- Study dates
- 14 Feb 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- BMI between 18 and 32 kg/m2
- Medically healthy without clinically significant or relevant medical history
Who cannot join
- Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
- Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
- Impaired renal function
- Cardiac abnormalities
- Positive HIV, HBsAg or HCV
- Positive test for alcohol, drugs of abuse or cotinine
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
CMAX Clinical Research
Adelaide, South Australia, 5000
Scientia Clinical Research
Randwick, New South Wales, 2031
About this study
Official title: A Phase 1 Safety, Tolerability and Pharmacokinetic Study of R-Idazoxan HCl Extended-Release (TR-01-XRR), S-Idazoxan HCl Extended-Release (TR-01-XRS) and Racemic Idazoxan HCl Extended-Release (TR-01-XR) in Healthy Participants
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.
- Conditions
- Healthy
- Being tested
- TR-01-XRR (1), TR-01-XRR (2), TR-01-XRR (3), TR-01-XRS, TR-01-XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-01-XRR (1)Drug
Also called R-Idazoxan HCL Extended Release (medium release rate) Tablet
Extended-release form
TR-01-XRR (2)Drug
Also called R-Idazoxan HCL Extended Release (faster release rate) Tablet
Extended-release form
TR-01-XRR (3)Drug
Also called R-Idazoxan HCL Extended Release (slower release rate) Tablet
Extended-release form
TR-01-XRSDrug
Also called S-Idazoxan Extended Release Tablet
Extended-release form
TR-01-XRDrug
Also called Racemic Idazoxan HCL Extended Release Tablet
Extended-release form
TR-01-IRDrug
Also called Idazoxan HCL Immediate Release Tablet
Active comparator
PlaceboDrug
Also called Matching Placebo Tablet
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Single Dose | Experimental | Parallel group comparison, single dose level of 5 forms of the investigational study drug. Receives: Drug: TR-01-XRR (1); Drug: TR-01-XRR (2); Drug: TR-01-XRR (3); Drug: TR-01-XRS; Drug: TR-01-XR |
| Part 2: Single escalating doses | Experimental | Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Receives: Drug: TR-01-XRR (1); Drug: TR-01-XRS; Drug: TR-01-XR; Drug: TR-01-IR; Drug: Placebo |
| Part 3: Multiple Dose | Experimental | Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. Receives: Drug: TR-01-XRR (1); Drug: TR-01-XRS; Drug: TR-01-XR; Drug: TR-01-IR; Drug: Placebo |
| Part 4: Food Effects | Experimental | Two-period single p.o. dose fasted/fed crossover separated by 5-day washout period. Dose to be determined by review of data from Part 2. Receives: Drug: TR-01-XRR (1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events based on clinical observation and participant report
Clinically observed adverse events include findings from physical examination, vital sign, ECG and laboratory assessments (hematological and clinical chemistry laboratory panels). Participant report includes any side effect reported by a participant during the study.
Measured: Through study completion up to 25 days after initial dose
Area under the plasma concentration-time curve (AUC)
To evaluate drug exposure over specified measurement time frame
Measured: Up to 120 hours after dose
Maximum plasma concentration (Cmax)
To evaluate peak drug concentration achieved during specified measurement time frame
Measured: Up to 120 hours after dose
Time to maximum plasma concentration (Tmax)
To evaluate time to achieve peak concentration during specified measurement time frame
Measured: Up to 120 hours after dose
Terminal elimination rate constant
To evaluate rate of drug elimination
Measured: Up to 120 hours after dose
Terminal elimination half-life (T1/2)
To evaluate time over which drug concentration is decreased by half
Measured: Up to 120 hours after dose
Apparent total clearance from plasma (CL/F)
To evaluate rate of drug clearance
Measured: Up to 120 hours after dose
Apparent volume of distribution (Vz/F)
To evaluate extent of drug distribution in the body
Measured: Up to 120 hours after dose
Secondary outcomes (1)
Relative bioavailability (Frel)
To compare single dose oral bioavailability in fed and fasted states
Measured: Over 120 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start14 Feb 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison. Part 4: Single-dose food effect cross-over.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terran Biosciences Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Fishman, MD, Study director, Clinical Lead Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727189
- Sponsor's protocol ID
- TR01-XR-101
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2023
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety, Tolerability and Pharmacokinetic Study of R-Idazoxan HCl Extended-Release (TR-01-XRR), S-Idazoxan HCl Extended-Release (TR-01-XRS) and Racemic Idazoxan HCl Extended-Release (TR-01-XR) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05727189
- Acronym / sponsor ID
- TR01-XR-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Terran Biosciences Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Feb 2023 (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.
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison. Part 4: Single-dose food effect cross-over.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Dose | Experimental | Drug: TR-01-XRR (1), Drug: TR-01-XRR (2), Drug: TR-01-XRR (3), Drug: TR-01-XRS, Drug: TR-01-XRParallel group comparison, single dose level of 5 forms of the investigational study drug. |
| Part 2: Single escalating doses | Experimental | Drug: TR-01-XRR (1), Drug: TR-01-XRS, Drug: TR-01-XR, Drug: TR-01-IR, Drug: PlaceboParallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. |
| Part 3: Multiple Dose | Experimental | Drug: TR-01-XRR (1), Drug: TR-01-XRS, Drug: TR-01-XR, Drug: TR-01-IR, Drug: PlaceboParallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. |
| Part 4: Food Effects | Experimental | Drug: TR-01-XRR (1)Two-period single p.o. dose fasted/fed crossover separated by 5-day washout period. Dose to be determined by review of data from Part 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18 and 32 kg/m2
- Medically healthy without clinically significant or relevant medical history
Key exclusion criteria (6 listed)
- Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
- Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
- Impaired renal function
- Cardiac abnormalities
- Positive HIV, HBsAg or HCV
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 |
|---|---|---|
| TR-01-XRR (1)Also: R-Idazoxan HCL Extended Release (medium release rate) TabletExtended-release form | Drug | Part 1 Single Dose, Part 2: Single escalating doses, Part 3: Multiple Dose, Part 4: Food Effects |
| TR-01-XRR (2)Also: R-Idazoxan HCL Extended Release (faster release rate) TabletExtended-release form | Drug | Part 1 Single Dose |
| TR-01-XRR (3)Also: R-Idazoxan HCL Extended Release (slower release rate) TabletExtended-release form | Drug | Part 1 Single Dose |
| TR-01-XRSAlso: S-Idazoxan Extended Release TabletExtended-release form | Drug | Part 1 Single Dose, Part 2: Single escalating doses, Part 3: Multiple Dose |
| TR-01-XRAlso: Racemic Idazoxan HCL Extended Release TabletExtended-release form | Drug | Part 1 Single Dose, Part 2: Single escalating doses, Part 3: Multiple Dose |
| TR-01-IRAlso: Idazoxan HCL Immediate Release TabletActive comparator | Drug | Part 2: Single escalating doses, Part 3: Multiple Dose |
| PlaceboAlso: Matching Placebo TabletPlacebo comparator | Drug | Part 2: Single escalating doses, Part 3: Multiple Dose |
Primary outcome
Number of participants with treatment-related adverse events based on clinical observation and participant report
Time frame: Through study completion up to 25 days after initial dose
Clinically observed adverse events include findings from physical examination, vital sign, ECG and laboratory assessments (hematological and clinical chemistry laboratory panels). Participant report includes any side effect reported by a participant during the study.
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 120 hours after dose
To evaluate drug exposure over specified measurement time frame
Maximum plasma concentration (Cmax)
Time frame: Up to 120 hours after dose
To evaluate peak drug concentration achieved during specified measurement time frame
Time to maximum plasma concentration (Tmax)
Time frame: Up to 120 hours after dose
To evaluate time to achieve peak concentration during specified measurement time frame
Terminal elimination rate constant
Time frame: Up to 120 hours after dose
To evaluate rate of drug elimination
Terminal elimination half-life (T1/2)
Time frame: Up to 120 hours after dose
To evaluate time over which drug concentration is decreased by half
Apparent total clearance from plasma (CL/F)
Time frame: Up to 120 hours after dose
To evaluate rate of drug clearance
Apparent volume of distribution (Vz/F)
Time frame: Up to 120 hours after dose
To evaluate extent of drug distribution in the body
1 secondary outcome
Relative bioavailability (Frel)
Time frame: Over 120 hours after dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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.
Robert Fishman, MD study director
Clinical Lead Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TR-01-XRR (1), TR-01-XRR (2) and TR-01-XRR (3) in people with Healthy, run by Terran Biosciences Australia Pty Ltd at 2 sites 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with treatment-related adverse events based on clinical observation and participant report (time frame: Through study completion up to 25 days after initial dose). The study lists 8 primary outcomes in all. 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 18 Mar 2026.