Treatment of Acute Zika Virus InfectionPhase 1NCT03443830
Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in Humans
A Phase 1 study testing Tyzivumab in people with Treatment of Acute Zika Virus Infection, run by Tychan Pte Ltd. at 1 site in Singapore.
Trial summary
Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly spreading throughout the continents since the first epidemic was reported in the French Polynesian islands. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Acute Zika Virus Infection
- What is being tested?
- Tyzivumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Feb 2018to 4 Dec 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must meet all the following criteria to be enrolled:
- Adult healthy volunteers, aged 21 to 45, men or women
- Women must fulfil one (1) of the following criteria: i. Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL ii. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation iii.Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening day until 100 days post-infusion b. Male subjects who are non-vasectomized (or vasectomized less than six (6) months prior to dosing) and have female partners of childbearing potential must be willing to use an effective birth control method when having heterosexual intercourse, from screening day until 100 days post-infusion
- Subjects negative for antibodies to flaviviruses as measured by a commercially available Dengue virus IgG enzyme-linked immunosorbent assay (ELISA) diagnostic kit
- Subjects negative for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV)
- Subjects who are willing to comply with the requirements of the study protocol and attend scheduled visit
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- Subjects who give written informed consent approved by the Ethical Review Board governing the site
- Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that are acceptable for study entry
- Accessible vein in the forearm for blood collection
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, or immunosuppressive disorders
- Evidence of clinically significant anaemia (HB < 10 g/dL) or any other significant active haematological disease, or having donated > 450 mL of blood within the past three (3) months
- Evidence of substance abuse, or previous substance abuse
- Participation or planned participation in a study involving the administration of an investigational compound within the past four (4) months or during this study period
- Planned administration of any vaccine not foreseen by the study protocol 12 weeks before first dosing day and up to four (4) months after dosing
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- Receipt of immunoglobulins and/or any blood products within nine (9) months of study enrolment or planned administration of any of these products during the study period
- History of any reaction to monoclonal antibodies
- Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 First in Human, Time Lagged, Parallel-Group, Single Ascending Dose Study of Tyzivumab in Healthy Adult Volunteers
Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly spreading throughout the continents since the first epidemic was reported in the French Polynesian islands.
Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.
Read more
This is a Phase 1, first in human, time-lagged, parallel-group, single dose ascending (6 dose cohorts), Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in 24 flaviviral naïve healthy adult volunteers.
Tyzivumab will be administered once through single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 98 days from the date of screening. Post-trial monitoring through weekly telephone calls will continue from Day 85 post-dose onwards for another three (3) more months.
The main objective of this study is to evaluate safety of Tyzivumab in healthy adult volunteers through assessment of subject vital signs, clinical laboratory results, ECG, presence/absence of AE/SAE, PK and ADA.
Read the detailed description
Dose escalation in this study will include 24 healthy volunteers in six (6) dose cohorts:
- 0.2 mg/kg, N = 2
- 0.5 mg/kg, N = 2
- 1 mg/kg, N = 2
- 5 mg/kg, N = 6
- 10 mg/kg, N = 6
- 20 mg/kg, N = 6
A minimum of 20-hour interval from the first dosing must take place before the second subject can be dosed within each cohort. No such time interval will be required for dosing of subsequent subjects (third subject onwards) within the same cohort.
Dose escalations will be guided by review of clinical signs, adverse events (AEs), and laboratory tests of the prior group (up to Day 7 after dosing) by a safety monitoring committee.
In order to assess the safety and tolerability of an intravenous (IV) infusion of Tyzivumab when given to healthy adult volunteers, the following vital signs and tests will be performed:
- Blood Pressure
- Pulse Rate
- Respiratory Rate
- Body Temperature
- ECG
- Urinalysis
- Serum Chemistry
- Haematology
In order to assess Tyzivumab pharmacokinetics (only for doses 1 mg/kg, 5 mg/kg, 10 mg/kg \& 20 mg/kg), the following parameters will be measured:
- maximum concentration (Cmax)
- time to maximum concentration (Tmax)
- area under the curve extrapolated to infinity (AUC0-∞)
- AUC calculated from time of administration to the last measurable concentration (AUC0-last)
- half-life (t1/2)
- volume of distribution (Vd)
- clearance [CL] in serum PK will be assessed at pre-dose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h, 72 h, 120 h, Day 7, Day 14, Day 28, Day 56 and Day 84.
The presence and extent of anti-drug antibody (ADA) production in response to dosing with Tyzivumab will also be assessed at pre-dose, Day 14, Day 56 and Day 84.
- Conditions
- Treatment of Acute Zika Virus Infection
- Being tested
- Tyzivumab
- Keywords
- Zika virus, Tyzivumab, Monoclonal antibody, Infectious diseases, Phase 1A first in human study, Singapore
- Medical subject headings
- Zika Virus Infection, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyzivumabDrug
Also called TY008
Tyzivumab Injection, (100 mg/5 mL/Vial), Zika Virus (ZIKV) Monoclonal Antibody (mAb) Infused over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 0.2 mg/kg | Experimental | Subject will be administered with 0.2 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
| 0.5 mg/kg | Experimental | Subject will be administered with 0.5 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
| 1 mg/kg | Experimental | Subject will be administered with 1 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
| 5 mg/kg | Experimental | Subject will be administered with 5 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
| 10 mg/kg | Experimental | Subject will be administered with 10 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
| 20 mg/kg | Experimental | Subject will be administered with 20 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. Receives: Drug: Tyzivumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Event (Safety and Tolerability)
Presence or absence of infusion reaction (hypersensitivity / anaphylaxis / etc.) in dose cohorts.
Measured: 84 days
Secondary outcomes (8)
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of Tyzivumab in human serum.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of Tyzivumab in human serum.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of Tyzivumab.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of Tyzivumab.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Half-Life (t1/2) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of Tyzivumab in human serum.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of Tyzivumab in human serum.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Clearance [CL] - Pharmacokinetic Assessment
Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of Tyzivumab in human serum.
Measured: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Anti-Drug Antibody Assessment
To assess the presence or absence of anti-drug antibody (ADA) production in response to dosing with Tyzivumab
Measured: Pre-dose, Day 14, Day 56 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start8 Feb 2018
- Primary completion12 Sep 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Acute Zika Virus InfectionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Time Lagged, Parallel-Group, Single Ascending Dose Study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tychan Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Clinical Research Institute, National University of Singapore, National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Jenny Low, MBBS, Principal investigator, SingHealth Investigational Medicine Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443830
- Sponsor's protocol ID
- ZKT-001
- Status last verified
- Apr 2019
- First submitted
- 8 Feb 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First in Human, Time Lagged, Parallel-Group, Single Ascending Dose Study of Tyzivumab in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03443830
- Acronym / sponsor ID
- ZKT-001
- Conditions
- Treatment of Acute Zika Virus Infection
- Keywords
- Zika virus, Tyzivumab, Monoclonal antibody, Infectious diseases, Phase 1A first in human study, Singapore
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tychan Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Clinical Research Institute, National University of Singapore, National University Hospital, Singapore
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 23 Feb 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.
Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly spreading throughout the continents since the first epidemic was reported in the French Polynesian islands.
Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.
This is a Phase 1, first in human, time-lagged, parallel-group, single dose ascending (6 dose cohorts), Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in 24 flaviviral naïve healthy adult volunteers.
Tyzivumab will be administered once through single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 98 days from the date of screening. Post-trial monitoring through weekly telephone calls will continue from Day 85 post-dose onwards for another three (3) more months.
The main objective of this study is to evaluate safety of Tyzivumab in healthy adult volunteers through assessment of subject vital signs, clinical laboratory results, ECG, presence/absence of AE/SAE, PK and ADA.
Detailed description
Dose escalation in this study will include 24 healthy volunteers in six (6) dose cohorts:
- 0.2 mg/kg, N = 2
- 0.5 mg/kg, N = 2
- 1 mg/kg, N = 2
- 5 mg/kg, N = 6
- 10 mg/kg, N = 6
- 20 mg/kg, N = 6
A minimum of 20-hour interval from the first dosing must take place before the second subject can be dosed within each cohort. No such time interval will be required for dosing of subsequent subjects (third subject onwards) within the same cohort.
Dose escalations will be guided by review of clinical signs, adverse events (AEs), and laboratory tests of the prior group (up to Day 7 after dosing) by a safety monitoring committee.
In order to assess the safety and tolerability of an intravenous (IV) infusion of Tyzivumab when given to healthy adult volunteers, the following vital signs and tests will be performed:
- Blood Pressure
- Pulse Rate
- Respiratory Rate
- Body Temperature
- ECG
- Urinalysis
- Serum Chemistry
- Haematology
In order to assess Tyzivumab pharmacokinetics (only for doses 1 mg/kg, 5 mg/kg, 10 mg/kg \& 20 mg/kg), the following parameters will be measured:
- maximum concentration (Cmax)
- time to maximum concentration (Tmax)
- area under the curve extrapolated to infinity (AUC0-∞)
- AUC calculated from time of administration to the last measurable concentration (AUC0-last)
- half-life (t1/2)
- volume of distribution (Vd)
- clearance [CL] in serum PK will be assessed at pre-dose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h, 72 h, 120 h, Day 7, Day 14, Day 28, Day 56 and Day 84.
The presence and extent of anti-drug antibody (ADA) production in response to dosing with Tyzivumab will also be assessed at pre-dose, Day 14, Day 56 and Day 84.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Time Lagged, Parallel-Group, Single Ascending Dose Study
| Arm | Type | Receives |
|---|---|---|
| 0.2 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 0.2 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
| 0.5 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 0.5 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
| 1 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 1 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
| 5 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 5 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
| 10 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 10 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
| 20 mg/kg | Experimental | Drug: TyzivumabSubject will be administered with 20 mg/kg of Tyzivumab via IV infusion over a period of 30 minutes. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult healthy volunteers, aged 21 to 45, men or women
- Subjects negative for antibodies to flaviviruses as measured by a commercially available Dengue virus IgG enzyme-linked immunosorbent assay (ELISA) diagnostic kit
- Subjects negative for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV)
- Subjects who are willing to comply with the requirements of the study protocol and attend scheduled visit
- Subjects who give written informed consent approved by the Ethical Review Board governing the site
Key exclusion criteria (10 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, or immunosuppressive disorders
- Evidence of clinically significant anaemia (HB < 10 g/dL) or any other significant active haematological disease, or having donated > 450 mL of blood within the past three (3) months
- Evidence of substance abuse, or previous substance abuse
- Participation or planned participation in a study involving the administration of an investigational compound within the past four (4) months or during this study period
- Planned administration of any vaccine not foreseen by the study protocol 12 weeks before first dosing day and up to four (4) months after dosing
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 |
|---|---|---|
| TyzivumabAlso: TY008Tyzivumab Injection, (100 mg/5 mL/Vial), Zika Virus (ZIKV) Monoclonal Antibody (mAb) Infused over 30 minutes | Drug | 0.2 mg/kg, 0.5 mg/kg, 1 mg/kg, 10 mg/kg, 20 mg/kg, 5 mg/kg |
Primary outcome
Incidence of Treatment-Emergent Adverse Event (Safety and Tolerability)
Time frame: 84 days
Presence or absence of infusion reaction (hypersensitivity / anaphylaxis / etc.) in dose cohorts.
8 secondary outcomes
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Half-Life (t1/2) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Clearance [CL] - Pharmacokinetic Assessment
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, 72 hour, 120 hour Day 7, Day 14, Day 28, Day 56 and Day 84.
Anti-Drug Antibody Assessment
Time frame: Pre-dose, Day 14, Day 56 and Day 84
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 10 Apr 2019.
- Individual participant dataSharing planned: Undecided
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.
Jenny Low, MBBS principal investigator
SingHealth Investigational Medicine Unit
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 Tyzivumab in people with Treatment of Acute Zika Virus Infection, run by Tychan Pte Ltd. at 1 site in Singapore.
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 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 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 Singapore. 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?
Incidence of Treatment-Emergent Adverse Event (Safety and Tolerability) (time frame: 84 days). 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 10 Apr 2019.