Erectile DysfunctionsPhase 1NCT07732387
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline
A Phase 1 study testing Viaca, Sildenafil 50 mg and Cabergoline 0.5 MG in people with Erectile Dysfunctions and Healthy Volunteer, run by Yanping Kong at 1 site in Australia.
Trial summary
This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunctions, Healthy Volunteer
- What is being tested?
- Viaca, Sildenafil 50 mg and Cabergoline 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2026to 19 Sep 2026
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants, aged 18 to 65 years (inclusive) at the time of informed consent.
- In good general health (Investigator judgement) with no significant medical history and no clinically significant abnormalities on physical examination, vital signs, or 12-lead ECG - including systolic blood pressure 110-140 mmHg (inclusive) at Screening and Day -1 - at Screening and/or before first IP administration.
- BMI ≥ 18.0 and ≤ 32.0 kg/m² and weight ≥ 50 kg.
- Nonsmoker or casual smoker (< 5 cigarettes/week equivalent) with no tobacco use within 2 months prior to Screening (Investigator discretion).
- Clinical laboratory values within normal range (or not clinically significant per Investigator).
- Fertile men agree to acceptable contraception from Screening until 90 days after last IP dose, and no sperm donation from first dose until ≥ 90 days after last dose.
- Able and willing to attend required study visits.
- Able and willing to provide written informed consent before any study procedures.
Who cannot join
- Physical or psychological condition that would impair protocol compliance or study completion (Investigator judgement).
- History of, or condition that would contraindicate study medication or interfere with study evaluations (Investigator judgement).
- Previous history of any of: myocardial infarction; cerebrovascular accident; arrhythmia; congestive heart failure; unstable angina; recent (<6 months) need for calcium-channel/beta-blocker/nitrate/anti-epileptic therapy; uncontrolled hypertension (SBP >140 or DBP >100 mmHg); hypotension (SBP <90 or DBP <60 mmHg) incl. syncope/orthostatic/vasovagal; pulmonary/pericardial/retroperitoneal fibrotic disorders; sickle-cell disease or trait; cardiac valve disease; severe psychiatric disorders; Raynaud's/vasospastic disorders; bariatric surgery (cholecystectomy acceptable).
- Blood/plasma donation or significant blood loss (450 mL) within 30 days prior to first IP dose.
- Fever (>38°C) or symptomatic viral/bacterial infection within 2 weeks prior to Screening.
- Infections requiring parenteral antibiotics within 1 month prior to Screening.
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- Concomitant use of an indwelling urethral catheter.
- Concomitant nitrates/nitric-oxide donors, potent CYP3A4 inhibitors (e.g. ritonavir, indinavir, ketoconazole) or moderate inhibitors (e.g. erythromycin); unwilling to avoid St. John's wort and CYP3A4-active herbals (e.g. grapefruit) within 14 days prior and throughout the study.
- Medications that significantly affect BP: nitrates (any form), alpha-blockers (e.g. doxazosin, terazosin, tamsulosin), guanylate cyclase stimulators (e.g. riociguat).
- Positive HCV antibody, HBsAg, or HIV antibody.
- Live vaccine within 4 weeks prior to first IP dose.
- Poor pill-swallowing ability or poor venous access.
- History of severe allergic/anaphylactic reactions or sensitivity to IP or constituents.
- History of malignancy (except non-melanoma skin cancer excised >5 years prior to Screening).
- Clinically significant abnormal Screening ECG (e.g. QRS ≥ 120 msec and/or QTcF > 450 msec, per Investigator).
- History/evidence of renal disease or eGFR < 60 mL/min/1.73 m² at Screening (2021 CKD-EPI creatinine equation).
- Immunosuppressive drug exposure (incl. experimental therapies) within 4 months or 5 half-lives (whichever longer) prior to Screening.
- Positive urine toxicology panel (barbiturates, THC, amphetamines/methamphetamines, methadone, MDMA, phencyclidine, tricyclic antidepressants, benzodiazepines, opiates, cocaine) or positive alcohol breath test.
- Unwilling to abstain from alcohol, caffeine and nicotine from 48 h prior to admission, during confinement, and 48 h prior to follow-up visits.
- History of substance abuse/dependency or recreational IV drug use in the last 12 months (self-declared).
- Unwilling to refrain from strenuous exercise (incl. weightlifting) 48 h prior to admission and follow-up visits.
- Anything the Investigator considers would jeopardize participant safety, prevent full participation, or compromise data interpretation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Coordinator at Nucleus Network Brisbane contact
About this study
Official title: An Open-Label Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline in Healthy Volunteers
This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male volunteers. Approximately 30 participants are enrolled across 5 sequential cohorts (6 each). Each participant receives a single oral dose. The combination targets erectile dysfunction through both vascular and neuroendocrine pathways, aiming for efficacy at lower component doses.
Read the detailed description
Five cohorts of 6 healthy male participants each (n≈30). Viaca dose cohorts: Cohort 1 (25/0.25 mg), Cohort 2 (50/0.5 mg), Cohort 3 (75/0.75 mg). Active-comparator cohorts: Cohort 4 (sildenafil 50 mg) and Cohort 5 (cabergoline 0.5 mg). Cohort 1 runs first; after Safety Review Committee (SRC) review of safety/tolerability/PK through Day 3, Cohorts 2, 4 and 5 may proceed in parallel; Cohort 3 proceeds after SRC review of Cohort 2. Participants fast ≥8 h overnight before dosing and 2 h after. They are confined to a Phase 1 unit and discharged on Day 5 (Cohorts 1-3 and 5) or Day 2 (Cohort 4), with a follow-up visit on Day 8 (±1). Total participation ~33 days including screening. (V2.0 amendment removed the former optional high-dose Viaca cohort.)
- Conditions
- Erectile Dysfunctions, Healthy Volunteer
- Being tested
- Viaca, Sildenafil 50 mg, Cabergoline 0.5 MG
- Keywords
- viaca, sildenafil, cabergoline, erectile dysfunction, PDE5 inhibitor, dopamine agonist, fixed-dose combination, single ascending dose, pharmacokinetics, healthy volunteers, Phase 1
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViacaDrug
fixed-dose oral tablet of sildenafil + cabergoline (low-dose 25/0.25 mg; high-dose 50/0.5 mg). Single oral dose.
Sildenafil 50 mgDrug
single oral dose
Cabergoline 0.5 MGDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Viaca 25/0.25 mg | Experimental | Single oral dose of Viaca (sildenafil 25 mg / cabergoline 0.25 mg; one low-dose tablet) in 6 healthy male participants. Receives: Drug: Viaca |
| Cohort 2: Viaca 50/0.5 mg | Experimental | Single oral dose of Viaca (sildenafil 50 mg / cabergoline 0.5 mg; one high-dose tablet Receives: Drug: Viaca |
| Cohort 3: Viaca 75/0.75 mg | Experimental | Single oral dose of Viaca (sildenafil 75 mg / cabergoline 0.75 mg; one low + one high tablet Receives: Drug: Viaca |
| Cohort 4: Sildenafil 50 mg | Active comparator | Single oral dose of sildenafil 50 mg (two 25 mg tablets). Receives: Drug: Sildenafil 50 mg |
| Cohort 5: Cabergoline 0.5 mg | Active comparator | Single oral dose of cabergoline 0.5 mg (one 0.5 mg tablet). Receives: Drug: Cabergoline 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with AEs/SAEs
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Unit: participants (summarised by severity and relatedness).
Measured: Day 1 (dosing) through Day 8
Blood pressure
Change from Baseline in systolic and diastolic blood pressure. Unit: mmHg.
Measured: Baseline through Day 8.
Pulse rate
Change from Baseline in pulse rate. Unit: beats/min.
Measured: Baseline through Day 8.
Respiratory rate
Change from Baseline in respiratory rate. Unit: breaths/min.
Measured: Baseline through Day 8.
Body temperature
Change from Baseline in body temperature. Unit: °C.
Measured: Baseline through Day 8.
ECG heart rate
Change from Baseline in 12-lead ECG heart rate. Unit: beats/min.
Measured: Baseline through Day 8.
ECG intervals
Change from Baseline in 12-lead ECG intervals (QTcF, PR, QRS). Unit: milliseconds.
Measured: Baseline through Day 8.
Laboratory tests
Number of participants with clinically significant safety laboratory abnormalities. Unit: participants.
Measured: Baseline through Day 8.
Physical examination
Number of participants with clinically significant physical examination findings. Unit: participants.
Measured: Baseline through Day 8.
Secondary outcomes (14)
Cmax
Maximum observed plasma concentration (Cmax). Unit: e.g. ng/mL.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
Tmax
Time to maximum plasma concentration (Tmax). Unit: hours.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-t
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t). Unit: e.g. ng·h/mL.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8)
AUC0-24
AUC from time 0 to 24 hours (AUC0-24). Unit: e.g. ng·h/mL.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf
AUC from time 0 extrapolated to infinity (AUC0-inf). Unit: e.g. ng·h/mL.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
%AUCextrap
Percentage of AUC0-inf obtained by extrapolation (%AUCextrap). Unit: percentage.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
t½
Apparent terminal elimination half-life (t½). Unit: hours.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
kel
Terminal elimination rate constant (kel). Unit: 1/hour.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
CL/F
Apparent total clearance after oral dosing (CL/F). Unit: e.g. L/h.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
Vz/F
Apparent volume of distribution during the terminal phase after oral dosing (Vz/F). Unit: e.g. L.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
Cmax/D
Dose-normalised maximum plasma concentration (Cmax/D). Unit: e.g. ng/mL per mg.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf/D
Dose-normalised AUC0-inf (AUC0-inf/D). Unit: e.g. ng·h/mL per mg.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-t/D
Dose-normalised AUC0-t (AUC0-t/D). Unit: e.g. ng·h/mL per mg.
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
Dose proportionality
Dose proportionality of Cmax and AUC across Viaca dose levels. Unit: e.g. slope (power-model estimate).
Measured: Predose (Day 1) through 168 hours post-dose (Day 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion19 Sep 2026 (estimated)
- Study completion19 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanping Kong
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor-investigator, Yanping Kong, Kong's Pharmaceutical
- Investigators
- Emma Trowbridge, MD, Principal investigator, Nucleus Network Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732387
- Sponsor's protocol ID
- CR-067-001
- Other IDs
- EC00372, 462/26
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07732387
- Acronym / sponsor ID
- CR-067-001
- Conditions
- Erectile Dysfunctions, Healthy Volunteer
- Keywords
- viaca, sildenafil, cabergoline, erectile dysfunction, PDE5 inhibitor, dopamine agonist, fixed-dose combination, single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yanping KongIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 19 Sep 2026 (estimated)
- Study completion
- 19 Sep 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male volunteers. Approximately 30 participants are enrolled across 5 sequential cohorts (6 each). Each participant receives a single oral dose. The combination targets erectile dysfunction through both vascular and neuroendocrine pathways, aiming for efficacy at lower component doses.
Detailed description
Five cohorts of 6 healthy male participants each (n≈30). Viaca dose cohorts: Cohort 1 (25/0.25 mg), Cohort 2 (50/0.5 mg), Cohort 3 (75/0.75 mg). Active-comparator cohorts: Cohort 4 (sildenafil 50 mg) and Cohort 5 (cabergoline 0.5 mg). Cohort 1 runs first; after Safety Review Committee (SRC) review of safety/tolerability/PK through Day 3, Cohorts 2, 4 and 5 may proceed in parallel; Cohort 3 proceeds after SRC review of Cohort 2. Participants fast ≥8 h overnight before dosing and 2 h after. They are confined to a Phase 1 unit and discharged on Day 5 (Cohorts 1-3 and 5) or Day 2 (Cohort 4), with a follow-up visit on Day 8 (±1). Total participation ~33 days including screening. (V2.0 amendment removed the former optional high-dose Viaca cohort.)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Viaca 25/0.25 mg | Experimental | Drug: ViacaSingle oral dose of Viaca (sildenafil 25 mg / cabergoline 0.25 mg; one low-dose tablet) in 6 healthy male participants. |
| Cohort 2: Viaca 50/0.5 mg | Experimental | Drug: ViacaSingle oral dose of Viaca (sildenafil 50 mg / cabergoline 0.5 mg; one high-dose tablet |
| Cohort 3: Viaca 75/0.75 mg | Experimental | Drug: ViacaSingle oral dose of Viaca (sildenafil 75 mg / cabergoline 0.75 mg; one low + one high tablet |
| Cohort 4: Sildenafil 50 mg | Active comparator | Drug: Sildenafil 50 mgSingle oral dose of sildenafil 50 mg (two 25 mg tablets). |
| Cohort 5: Cabergoline 0.5 mg | Active comparator | Drug: Cabergoline 0.5 MGSingle oral dose of cabergoline 0.5 mg (one 0.5 mg tablet). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male participants, aged 18 to 65 years (inclusive) at the time of informed consent.
- In good general health (Investigator judgement) with no significant medical history and no clinically significant abnormalities on physical examination, vital signs, or 12-lead ECG - including systolic blood pressure 110-140 mmHg (inclusive) at Screening and Day -1 - at Screening and/or before first IP administration.
- BMI ≥ 18.0 and ≤ 32.0 kg/m² and weight ≥ 50 kg.
- Nonsmoker or casual smoker (< 5 cigarettes/week equivalent) with no tobacco use within 2 months prior to Screening (Investigator discretion).
- Clinical laboratory values within normal range (or not clinically significant per Investigator).
Key exclusion criteria (22 listed)
- Physical or psychological condition that would impair protocol compliance or study completion (Investigator judgement).
- History of, or condition that would contraindicate study medication or interfere with study evaluations (Investigator judgement).
- Previous history of any of: myocardial infarction; cerebrovascular accident; arrhythmia; congestive heart failure; unstable angina; recent (<6 months) need for calcium-channel/beta-blocker/nitrate/anti-epileptic therapy; uncontrolled hypertension (SBP >140 or DBP >100 mmHg); hypotension (SBP <90 or DBP <60 mmHg) incl. syncope/orthostatic/vasovagal; pulmonary/pericardial/retroperitoneal fibrotic disorders; sickle-cell disease or trait; cardiac valve disease; severe psychiatric disorders; Raynaud's/vasospastic disorders; bariatric surgery (cholecystectomy acceptable).
- Blood/plasma donation or significant blood loss (450 mL) within 30 days prior to first IP dose.
- Fever (>38°C) or symptomatic viral/bacterial infection within 2 weeks prior to Screening.
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 |
|---|---|---|
| Viacafixed-dose oral tablet of sildenafil + cabergoline (low-dose 25/0.25 mg; high-dose 50/0.5 mg). Single oral dose. | Drug | Cohort 1: Viaca 25/0.25 mg, Cohort 2: Viaca 50/0.5 mg, Cohort 3: Viaca 75/0.75 mg |
| Sildenafil 50 mgsingle oral dose | Drug | Cohort 4: Sildenafil 50 mg |
| Cabergoline 0.5 MGsingle oral dose | Drug | Cohort 5: Cabergoline 0.5 mg |
Primary outcome
Participants with AEs/SAEs
Time frame: Day 1 (dosing) through Day 8
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Unit: participants (summarised by severity and relatedness).
Blood pressure
Time frame: Baseline through Day 8.
Change from Baseline in systolic and diastolic blood pressure. Unit: mmHg.
Pulse rate
Time frame: Baseline through Day 8.
Change from Baseline in pulse rate. Unit: beats/min.
Respiratory rate
Time frame: Baseline through Day 8.
Change from Baseline in respiratory rate. Unit: breaths/min.
Body temperature
Time frame: Baseline through Day 8.
Change from Baseline in body temperature. Unit: °C.
ECG heart rate
Time frame: Baseline through Day 8.
Change from Baseline in 12-lead ECG heart rate. Unit: beats/min.
ECG intervals
Time frame: Baseline through Day 8.
Change from Baseline in 12-lead ECG intervals (QTcF, PR, QRS). Unit: milliseconds.
Laboratory tests
Time frame: Baseline through Day 8.
Number of participants with clinically significant safety laboratory abnormalities. Unit: participants.
Physical examination
Time frame: Baseline through Day 8.
Number of participants with clinically significant physical examination findings. Unit: participants.
14 secondary outcomes
Cmax
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Tmax
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-t
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8)
AUC0-24
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
%AUCextrap
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
t½
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
kel
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
CL/F
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Vz/F
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Cmax/D
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf/D
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-t/D
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Dose proportionality
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
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 28 Jul 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.
Clinical Research Coordinator at Nucleus Network Brisbane contact
Emma Trowbridge, MD principal investigator
Nucleus Network Brisbane
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 Viaca, Sildenafil 50 mg and Cabergoline 0.5 MG in people with Erectile Dysfunctions and Healthy Volunteer, run by Yanping Kong 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 8 inclusion and 22 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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. 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?
Contact Clinical Research Coordinator at Nucleus Network Brisbane (1800 243 733, brisbane@nucleusnetwork.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with AEs/SAEs (time frame: Day 1 (dosing) through Day 8). The study lists 9 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 28 Jul 2026.