Healthy VolunteersPhase 1ALVOPADNCT03579823
Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers
A Phase 1 study testing Adalimumab 100 MG/ML [Humira] and AVT02 100MG/ML in people with Healthy Volunteers, run by Alvotech Swiss AG at 1 site in Australia.
Trial summary
Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Adalimumab 100 MG/ML [Humira] and AVT02 100MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 21 May 2018to 24 Aug 2018
- 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
Main Inclusion Criteria:
- Male and female healthy adult subjects willing to sign an Informed Consent Form and able to undergo protocol related procedures.
- Age: 18 to 55 years, inclusive.
- Body Mass Index (BMI): 19.0 to 30.0 kg per m2.
- Medical history without major pathology, at the discretion of Principal Investigator.
- Resting supine systolic blood pressure of ≤150 mmHg and diastolic blood pressure of ≤90 mmHg. Other vital signs showing no clinically relevant deviations according to the Principal Investigator's judgment.
- Computerised 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal Investigator.
- Subjects who do not smoke tobacco products or use nicotine replacement therapy or e-cigarettes.
Main Exclusion Criteria:
- Evidence of clinically relevant pathology.
- Unable to follow protocol instructions in the opinion of the Principal Investigator.
- History of relevant drug and or food allergies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Known history of previous exposure to adalimumab or other anti-TNF-alpha molecules.
- Any past or concurrent medical conditions potentially increasing the subject's risks, or would have interfered with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., malignancies, demyelinating disorders, herpes zoster, or hepatic, gallbladder or pancreatic diseases).
- Presence of chronic obstructive pulmonary disease. Asthma in the childhood is allowed.
- Evidence of a recent, within 6 months, infection requiring hospitalisation or intravenous antibiotic use.
- Subject has a positive test for Tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB.
- Having received live vaccines during the 4 weeks before screening or have the intention to receive vaccination during the study.
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV) 1 on 2 antibodies at screening.
- Impaired liver function
- Any persons who are an employee of the Principal Investigator, clinical centre, clinical research organisation or Sponsor, a relative of an employee of the clinical centre, the Investigator, Clinical Research Organization (CRO) or the Sponsor.
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Centre, Randomised, Single-Blind, Pilot Study to Compare the Safety, Tolerability and Pharmacokinetics of AVT02 to EU-approved Humira® as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adult Subjects (ALVOPAD)
Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others.
Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need.
Read more
Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient.
The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Adalimumab 100 MG/ML [Humira], AVT02 100MG/ML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab 100 MG/ML [Humira]Drug
prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1
AVT02 100MG/MLDrug
prefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1
| Study group | Role | What they receive |
|---|---|---|
| AVT02 100 MG/ML | Experimental | Single subcutaneous injection of 40 mg of AVT02 (100MG/ML) Receives: Drug: AVT02 100MG/ML |
| Adalimumab 100 MG/ML [HUMIRA] | Active comparator | Single subcutaneous injection of 40 mg of Adalimumab (100MG/ML) [HUMIRA] Receives: Drug: Adalimumab 100 MG/ML [Humira] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measurement of blood pressure (systolic and diastolic in mm Hg)
Measured: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Change from baseline heart rate at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measure of heart rate (beats per minute)
Measured: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Change from baseline body temperature at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measurement of oral temperature (Celsius degree)
Measured: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Change from baseline electrocardiogram at 1, 2, 5, 9, 64 days post dosing
Analysis of 12-lead electrocardiogram
Measured: Predose and 1, 2, 5, 9, 64 days post dosing
Change from baseline red blood cells at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure red blood cells count, (unit/mm3)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline haemoglobin at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure haemoglobin (g/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline white blood cells at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure white blood cells count, (unit/mm3)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline platelets at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure platelets count, (unit/mm3)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood gamma glutamyl transferase at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure gamma glutamyl transferase (UI/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood aspartate aminotransferase at 2, 3, 5, 9, 64 days post
Blood collection to measure aspartate aminotransferase (UI/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood alanine aminotransferase at 2, 3, 5, 9, 64 days post
Blood collection to measure alanine aminotransferase (UI/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood potassium at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure potassium (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood sodium at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure sodium (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood calcium at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure calcium (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood phosphate at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure phosphate (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood chloride at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure chloride (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood bicarbonate at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure bicarbonate (mmol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood creatinine at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure creatinine (micromol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline blood bilirubin at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure Bilirubin (micromol/L)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline international normalised ratio at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure international normalised ratio
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline prothrombin time at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure prothrombin time (sec)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline partial prothrombin time at 2, 3, 5, 9, 64 days post dosing
Blood collection to measure partial prothrombin time (sec)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline activated partial thromboplastin time at 2, 3, 5, 9, 64 days post
Blood collection to measure activated partial thromboplastin time (sec)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline thrombin time at 2, 3, 5, 9, 64 days post
Blood collection to measure thrombin time (sec)
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline urine leucocytes at 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure leucocytes
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline urine glucose at 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure glucose
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Change from baseline urine protein at 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure protein
Measured: Predose and 2, 3, 5, 9, 64 days post dosing
Secondary outcomes (7)
Area under the plasma concentration-time curve (AUC)
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC) of AVT02 and EU Humira
Measured: Over 64 days
Maximum serum concentration
Venous blood samples will be collected for measurement of serum concentration of AVT02 and EU Humira
Measured: Over 64 days
Time to maximum serum concentration
Evaluation of time to maximum plasma concentration (Tmax) of AVT02 and Humira.
Measured: Over 64 days
Terminal half-life
Evaluation of terminal elimination half-life (T1/2) of AVT02 and Humira
Measured: Over 64 days
Volume of distribution
Evaluation of volume of distribution during the elimination phase (Vz) of AVT02 and Humira
Measured: Over 64 days
Clearance
Evaluation of total plasma clearance (CL) of AVT02 and Humira
Measured: Over 64 days
Incidence and titer of anti-drug antibodies to adalimumab
A blood sample will be collected to measure antibodies to AVT02 and Humira
Measured: 15, 29 and 64 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start21 May 2018
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single Centre, Randomised, Single-Blind, Pilot Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579823
- Sponsor's protocol ID
- AVT02-GL-100
- Acronym
- ALVOPAD
- Status last verified
- Jan 2019
- First submitted
- 8 Jun 2018
- Last updated
- 18 Jan 2019
- 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 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre, Randomised, Single-Blind, Pilot Study to Compare the Safety, Tolerability and Pharmacokinetics of AVT02 to EU-approved Humira® as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adult Subjects (ALVOPAD)
- ClinicalTrials.gov ID
- NCT03579823
- Acronym / sponsor ID
- ALVOPAD / AVT02-GL-100
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 9 Jul 2018 (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.
Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others.
Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need.
Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient.
The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Centre, Randomised, Single-Blind, Pilot Study
| Arm | Type | Receives |
|---|---|---|
| AVT02 100 MG/ML | Experimental | Drug: AVT02 100MG/MLSingle subcutaneous injection of 40 mg of AVT02 (100MG/ML) |
| Adalimumab 100 MG/ML [HUMIRA] | Active comparator | Drug: Adalimumab 100 MG/ML [Humira]Single subcutaneous injection of 40 mg of Adalimumab (100MG/ML) [HUMIRA] |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Adalimumab 100 MG/ML [Humira]prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1 | Drug | Adalimumab 100 MG/ML [HUMIRA] |
| AVT02 100MG/MLprefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1 | Drug | AVT02 100 MG/ML |
Primary outcome
Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Time frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measurement of blood pressure (systolic and diastolic in mm Hg)
Change from baseline heart rate at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Time frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measure of heart rate (beats per minute)
Change from baseline body temperature at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Time frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Measurement of oral temperature (Celsius degree)
Change from baseline electrocardiogram at 1, 2, 5, 9, 64 days post dosing
Time frame: Predose and 1, 2, 5, 9, 64 days post dosing
Analysis of 12-lead electrocardiogram
Change from baseline red blood cells at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure red blood cells count, (unit/mm3)
Change from baseline haemoglobin at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure haemoglobin (g/L)
Change from baseline white blood cells at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure white blood cells count, (unit/mm3)
Change from baseline platelets at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure platelets count, (unit/mm3)
Change from baseline blood gamma glutamyl transferase at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure gamma glutamyl transferase (UI/L)
Change from baseline blood aspartate aminotransferase at 2, 3, 5, 9, 64 days post
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure aspartate aminotransferase (UI/L)
Change from baseline blood alanine aminotransferase at 2, 3, 5, 9, 64 days post
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure alanine aminotransferase (UI/L)
Change from baseline blood potassium at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure potassium (mmol/L)
Change from baseline blood sodium at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure sodium (mmol/L)
Change from baseline blood calcium at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure calcium (mmol/L)
Change from baseline blood phosphate at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure phosphate (mmol/L)
Change from baseline blood chloride at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure chloride (mmol/L)
Change from baseline blood bicarbonate at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure bicarbonate (mmol/L)
Change from baseline blood creatinine at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure creatinine (micromol/L)
Change from baseline blood bilirubin at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure Bilirubin (micromol/L)
Change from baseline international normalised ratio at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure international normalised ratio
Change from baseline prothrombin time at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure prothrombin time (sec)
Change from baseline partial prothrombin time at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure partial prothrombin time (sec)
Change from baseline activated partial thromboplastin time at 2, 3, 5, 9, 64 days post
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure activated partial thromboplastin time (sec)
Change from baseline thrombin time at 2, 3, 5, 9, 64 days post
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Blood collection to measure thrombin time (sec)
Change from baseline urine leucocytes at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure leucocytes
Change from baseline urine glucose at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure glucose
Change from baseline urine protein at 2, 3, 5, 9, 64 days post dosing
Time frame: Predose and 2, 3, 5, 9, 64 days post dosing
Urine sample collection to measure protein
7 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: Over 64 days
Maximum serum concentration
Time frame: Over 64 days
Time to maximum serum concentration
Time frame: Over 64 days
Terminal half-life
Time frame: Over 64 days
Volume of distribution
Time frame: Over 64 days
Clearance
Time frame: Over 64 days
Incidence and titer of anti-drug antibodies to adalimumab
Time frame: 15, 29 and 64 days after dosing
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 18 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adalimumab 100 MG/ML [Humira] and AVT02 100MG/ML in people with Healthy Volunteers, run by Alvotech Swiss AG 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?
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 18 Jan 2019. 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?
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?
Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing (time frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing). The study lists 27 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 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.