RESPIRATORY SYNCYTIAL VIRUS INFECTIONSPhase 2VICTORNCT02654171
Viral Inhibition in Children for Treatment of RSV
A Phase 2 study testing AK0529 in people with RESPIRATORY SYNCYTIAL VIRUS INFECTIONS, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 28 sites in 8 countries.
Trial summary
VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- RESPIRATORY SYNCYTIAL VIRUS INFECTIONS
- What is being tested?
- AK0529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 27 May 2016to 9 Apr 2019
- Phase
- Phase 2
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- Diagnosis of RSV infection by virological means, which may include rapid diagnostic point-of-care testing, within 96 hours preceding screening for Part 1 and 72 hours for Part 2.
- Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles (inclusive) for the patient's age, based on the local child growth standards, i.e. the Australian Paediatric Endocrine Group Growth Charts.
- The parent / legal guardian of the patient must have provided written informed consent for the patient to participate.
- For patients aged <12 months, an occipito-frontal head circumference within the normal range for age and gender.
Who cannot join
- The patient has taken, is currently taking or requires any restricted medications.
- Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months).
- Participation in an investigational drug or device study within 30 days prior to the date of screening.
- Requires vasopressors or inotropic support at the time of enrolment.
- Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
- Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrolment.
Show all 20Show fewer
- Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
- Left to right shunt meriting corrective therapy.
- Renal failure including renal anomalies likely to be associated with renal insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis).
- Clinical evidence of hepatic decompensation (e.g. hepatic disorder with associated coagulopathy or associated encephalopathy).
- Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or seizures.
- Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders, disorders of carbohydrate metabolism, glycogen storage disorders).
- Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia, common variable immunodeficiency, immunosuppressive therapy other than glucocorticoid or montelukast therapy forming part of care directed by the treating physician).
- For Part 2 of this study, children with a history of having received palivizumab or any other monoclonal agent directed against RSV in the preceding 120 days. This exclusion criterion does not apply to Part 1.
- Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment.
- A history of epilepsy or seizures including febrile seizures.
- Allergy to test medication or constituents.
- Weight less than 10th percentile or greater than 90th percentile for age and gender adjusted for any prematurity.
- The patient's parent or legally acceptable representative is an employee of the investigator or the study center, with direct involvement in the proposed study or other studies under the direction of that investigator of the study center, or any family members of the employees or the investigator.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Malaysia5 sites
Hospital Selayang
Batu Caves, Selangor
Hospital Tengku Ampuan Rahimah
Klang, Selangor
University Malaya Medical Center
Kuala Lumpur
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan
Hospital Sibu
Sibu, Sarawak
Taiwan5 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Municipal Wanfang Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
Lebanon4 sites
American University of Beirut Medical Center
Beirut
Makassed General Hospital
Beirut
Rafik Hariri University Hospital
Beirut
Saint George Hospital University Medical Center
Beirut
Turkey (Türkiye)4 sites
Cukurova University Balcali Hospital
Adana, Adana
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, Eskişehir
Marmara University Faculty of Medicine
Istanbul
Ege University Medical Faculty
Izmir, İzmir
Australia3 sites
Women's and Children's Hospital
Adelaide, South Australia
Gold Coast University Hospital
Gold Coast, Queensland
Lady Cilento Children's Hospital
South Brisbane, Queensland, 4101
Israel3 sites
Soroka University Medical Center
Beersheba
Ruth Rappaport Children's Hospital
Haifa
Schneider Children's Medical Center
Petach Tikvah
Poland3 sites
Nowy Szpital w Świeciu
Gmina Świecie, Kujawy-Pomerania
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
Poznan, Greater Poland Voivodeship
Szpital im. Świętej Jadwigi Śląskiej w Trzebnicy
Trzebnica, Trzebnica County
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalized Infants With Respiratory Syncytial Virus Infection
VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.
Read the detailed description
Globally, Respiratory Syncytial Virus (RSV) is recognized as the leading cause of respiratory tract infections in infants and young children and a major cause of hospitalization due to severe respiratory infection. Despite four decades of effort, there are still no effective methods to control RSV infection. Treatment of RSV has been limited to supportive measures. There is an urgent need for safe and effective drugs to treat and prevent RSV disease.
AK0529 is an investigational antiviral agent that targets the RSV fusion protein on the surface of the viral envelope and exerts antiviral activity against RSV by inhibiting viral entry into host cells and preventing fusion protein induced cell-cell fusion. AK0529 was generally well tolerated in healthy volunteers.
This study is designed as a randomized, double-blind, placebo-controlled, multicenter, phase 2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection. It will consist of two parts, Part 1 and Part 2. Each part will consist of three phases, a pre-treatment phase, a treatment phase and post-treatment follow-up phase.
- Conditions
- RESPIRATORY SYNCYTIAL VIRUS INFECTIONS
- Being tested
- AK0529, Placebo
- Keywords
- RSV, AK0529
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK0529Drug
AK0529 is a novel compound being developed for the treatment of RSV infection. The enteric coated drug pellets with sugar core can be administered orally with apple sauce/purée or yoghurt, or by flushing with 10% dextrose water via a nasogastric or other feeding tube, or upon a glucose wafer.
PlaceboDrug
The placebo was made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed primarily of microcrystaline cellulose pellet.
| Study group | Role | What they receive |
|---|---|---|
| AK0529 | Experimental | Subjects will receive single or multiple doses of AK0529 at different dose levels within different cohorts. Receives: Drug: AK0529 |
| Placebo | Placebo comparator | Patients who are randomized to the control arm within each cohort will receive the corresponding placebo to AK0529. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events during the study
Measured: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
Subject withdrawals due to Adverse Events
Measured: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
Secondary outcomes (8)
Area under the plasma concentration-time curve from time 0 to infinity (AUC)
For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Measured: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Maximum plasma concentration of AK0529 (Cmax)
For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Measured: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Plasma concentration of AK0529 at 12 hours postdose (C12)
For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Measured: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Apparent total body clearance (CL/F)
For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Measured: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Apparent central compartment volume of distribution (Vc/F)
For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Measured: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Area under curve change of viral load
The antiviral effects in infants hospitalized with RSV are to be determined by measuring the RSV viral load area under the curve in nasal, pharyngeal and tracheal washes / aspirates from baseline to last administration of study medication (Day 5).
Measured: From baseline to Day 5
Incidence of F-protein genotypes
The incidence of F-protein genotypes associated with reduced sensitivity to IMP will be evaluated.
Measured: Specimen will be collected predose and 24 hours postdose on Day 1 (Part 1) and on Day 1-5 (Part 2).
Change of symptom score
To evaluate the change of RSV related symptom score in AK0529 arms compared with the change in placebo arm after treatment. The total score is reported with a range from 0 to 12. A decreasing value of total score represents clinical improvement. Subscales are not applicable in this symptom score.
Measured: From baseline to Day 1 (Part 1) and up to Day 5 after multiple drug administration (Part 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start27 May 2016
- Primary completion31 Mar 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RESPIRATORY SYNCYTIAL VIRUS INFECTIONSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ark Biosciences Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Ark Clinical Trial, Study director, info@arkbiosciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654171
- Sponsor's protocol ID
- AK0529-1003
- Acronym
- VICTOR
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2016
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PubMed 20399493Huang LM, Schibler A, Huang YC, Tai A, Chi H, Chieng CH, Wang JL, Goldbart A, Tang SP, Huang YC, George S, Alabaz D, Bentur L, Su SC, de Bruyne J, Karadag B, Gu F, Zou G, Toovey S, DeVincenzo JP, Wu JZ. Safety and efficacy of AK0529 in respiratory syncytial virus-infected infant patients: A phase 2 proof-of-concept trial. Influenza Other Respir Viruses. 2023 Jul 25;17(7):e13176. doi: 10.1111/irv.13176. eCollection 2023 Jul.
PubMed 37502622
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalized Infants With Respiratory Syncytial Virus Infection
- ClinicalTrials.gov ID
- NCT02654171
- Acronym / sponsor ID
- VICTOR / AK0529-1003
- Conditions
- RESPIRATORY SYNCYTIAL VIRUS INFECTIONS
- Keywords
- RSV, AK0529
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ark Biosciences Pty Ltd.
- Study start
- 27 May 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 13 Jan 2016 (estimated)
- 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.
VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.
Detailed description
Globally, Respiratory Syncytial Virus (RSV) is recognized as the leading cause of respiratory tract infections in infants and young children and a major cause of hospitalization due to severe respiratory infection. Despite four decades of effort, there are still no effective methods to control RSV infection. Treatment of RSV has been limited to supportive measures. There is an urgent need for safe and effective drugs to treat and prevent RSV disease.
AK0529 is an investigational antiviral agent that targets the RSV fusion protein on the surface of the viral envelope and exerts antiviral activity against RSV by inhibiting viral entry into host cells and preventing fusion protein induced cell-cell fusion. AK0529 was generally well tolerated in healthy volunteers.
This study is designed as a randomized, double-blind, placebo-controlled, multicenter, phase 2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection. It will consist of two parts, Part 1 and Part 2. Each part will consist of three phases, a pre-treatment phase, a treatment phase and post-treatment follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK0529 | Experimental | Drug: AK0529Subjects will receive single or multiple doses of AK0529 at different dose levels within different cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboPatients who are randomized to the control arm within each cohort will receive the corresponding placebo to AK0529. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female patients of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- Diagnosis of RSV infection by virological means, which may include rapid diagnostic point-of-care testing, within 96 hours preceding screening for Part 1 and 72 hours for Part 2.
- Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles (inclusive) for the patient's age, based on the local child growth standards, i.e. the Australian Paediatric Endocrine Group Growth Charts.
- The parent / legal guardian of the patient must have provided written informed consent for the patient to participate.
- For patients aged <12 months, an occipito-frontal head circumference within the normal range for age and gender.
Key exclusion criteria (20 listed)
- The patient has taken, is currently taking or requires any restricted medications.
- Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months).
- Participation in an investigational drug or device study within 30 days prior to the date of screening.
- Requires vasopressors or inotropic support at the time of enrolment.
- Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
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 |
|---|---|---|
| AK0529AK0529 is a novel compound being developed for the treatment of RSV infection. The enteric coated drug pellets with sugar core can be administered orally with apple sauce/purée or yoghurt, or by flushing with 10% dextrose water via a nasogastric or other feeding tube, or upon a glucose wafer. | Drug | AK0529 |
| PlaceboThe placebo was made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed primarily of microcrystaline cellulose pellet. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events during the study
Time frame: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
Subject withdrawals due to Adverse Events
Time frame: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
8 secondary outcomes
Area under the plasma concentration-time curve from time 0 to infinity (AUC)
Time frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Maximum plasma concentration of AK0529 (Cmax)
Time frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Plasma concentration of AK0529 at 12 hours postdose (C12)
Time frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Apparent total body clearance (CL/F)
Time frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Apparent central compartment volume of distribution (Vc/F)
Time frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Area under curve change of viral load
Time frame: From baseline to Day 5
Incidence of F-protein genotypes
Time frame: Specimen will be collected predose and 24 hours postdose on Day 1 (Part 1) and on Day 1-5 (Part 2).
Change of symptom score
Time frame: From baseline to Day 1 (Part 1) and up to Day 5 after multiple drug administration (Part 2).
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 2024.
- Background: PubMed 20399493Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Results publication: PubMed 37502622Huang LM, Schibler A, Huang YC, Tai A, Chi H, Chieng CH, Wang JL, Goldbart A, Tang SP, Huang YC, George S, Alabaz D, Bentur L, Su SC, de Bruyne J, Karadag B, Gu F, Zou G, Toovey S, DeVincenzo JP, Wu JZ. Safety and efficacy of AK0529 in respiratory syncytial virus-infected infant patients: A phase 2 proof-of-concept trial. Influenza Other Respir Viruses. 2023 Jul 25;17(7):e13176. doi: 10.1111/irv.13176. eCollection 2023 Jul.
- 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.
Ark Clinical Trial study director
info@arkbiosciences.com
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK0529 in people with RESPIRATORY SYNCYTIAL VIRUS INFECTIONS, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 28 sites in 8 countries.
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 5 inclusion and 20 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Malaysia, Taiwan, Lebanon, Turkey (Türkiye), Australia and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of Adverse Events during the study (time frame: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654171, which also lists 2 linked publications.
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 2024.