Coronavirus Disease-2019 (COVID-19)Phase 1NCT04429529
Safety of TY027, a Treatment for COVID-19, in Humans
A Phase 1 study testing TY027 and 0.9% Saline in people with Coronavirus Disease-2019 (COVID-19), run by Tychan Pte Ltd. at 1 site in Singapore.
Trial summary
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease-2019 (COVID-19)
- What is being tested?
- TY027 and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Jun 2020to 20 Jan 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers, aged 21 to 50 years old, men or women
- Subjects negative for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus surface Antigen (HBsAg) and Hepatitis C virus (HCV antibody screen)
- Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and make themselves available for the duration of the study with access to a consistent means of telephone contact, which may be, but not limited to, at home or at work via landline or mobile
- 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 a stable health status. Normal laboratory values must be within normal range of the assessing site or show minor variations that are deemed not clinically significant as judged by the Investigator and acceptable for study entry. A stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event
- Accessible vein in the forearm for blood collection
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- Female subjects of childbearing potential may be enrolled in the study if they have negative urine pregnancy tests on the day of screening and day of admission
- Female subjects of non-childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post- menopause subjects must have had at least 12 months of natural (spontaneous) amenorrhea
- Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) must agree to use adequate and reliable contraceptive measures (e.g. spermicides, condoms, contraceptive pills, etc.) or practice abstinence throughout the duration of the study (up to 84 days post-dosing)
Who cannot join
- Subject previously diagnosed with COVID-19 or had been issued with a quarantine order by the Ministry of Health
- Presence of acute infection in the preceding 14 days, or presence of a temperature ≥ 38.0 ˚C (oral or tympanic temperature assessment), or acute symptoms of any severity on the scheduled date of admission
- History of severe drug and / or food allergies and / or known allergies to the trial product or its components
- Female subject who is pregnant or breast-feeding
- 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
Show all 12Show fewer
- 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
- 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
- Administration of any licensed vaccine within 30 days before the first study vaccine dose.
- History of any reaction to monoclonal antibodies
- Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the subject
- Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) who are unwilling to use adequate contraception or practice abstinence throughout the duration of the study (up to 84 days post-dosing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic.
To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Read the detailed description
This is a Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers.
Safety, tolerability and PK of TY027 will be assessed. The dose escalation will include 32 healthy volunteers across five (5) dose cohorts:
- 0.5 mg/kg, N = 2 TY027 + 2 Placebos
- 5 mg/kg, N = 5 TY027 + 2 Placebos
- 10 mg/kg, N = 5 TY027 + 2 Placebos
- 20 mg/kg, N = 5 TY027 + 2 Placebos
- 30 mg/kg, N = 5 TY027 + 2 Placebos
Subjects will be required to be inpatient at the trial site for approximately 24 hours.
A minimum of 20-hour interval from the first two (2) subjects dosing (1 treatment and 1 placebo concurrently) must take place before the third subject can be dosed within the cohort. No such time interval will be required for dosing of subsequent subjects (fourth subject onwards) within the same dose cohort.
After 24 hours, subjects will be discharged from the trial site and to return for scheduled follow-up visits. Subjects will be followed for up to approximately Day 84 with serum samples taken at specified times as per outlines in Table 1.
Dose escalations will be guided by a safety review of clinical signs, adverse events (AEs), laboratory tests (excluding lipase) and immune gene expression data of the prior dose cohort (up to 72 hours post-dose). Subsequent post-trial monitoring through weekly telephone calls will continue from Day 85 onwards for another three (3) more months.
Decisions not to dose escalate past any proposed dose level due to safety findings will not constitute a protocol violation.
Safety summaries (up to Day 3 post-dose) will be generated for each dose cohort and delivered to the Dose Escalation Review Committee (DERC) for review.
Interim analysis will be performed after Day 14 post-dose for each dose cohort and delivered to the Data Safety Monitoring Board (DSMB) for review.
- Conditions
- Coronavirus Disease-2019 (COVID-19)
- Being tested
- TY027, 0.9% Saline
- Keywords
- Coronavirus Disease-2019, COVID-19, SARS-CoV-2, Monoclonal Antibody, Infectious diseases, Phase 1 first in human study, Singapore
- Medical subject headings
- COVID-19, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY027Biological
TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb)
0.9% SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TY027 0.5 mg/kg | Experimental | Subject will be administered with 0.5 mg/kg of TY027 via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo 0.5 mg/kg | Placebo comparator | Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. Receives: Other: 0.9% Saline |
| TY027 5mg/kg | Experimental | Subject will be administered with 5 mg/kg of TY027 via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo 5 mg/kg | Placebo comparator | Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. Receives: Other: 0.9% Saline |
| TY027 10 mg/kg | Experimental | Subject will be administered with 10 mg/kg of TY027 via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo 10 mg/kg | Placebo comparator | Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. Receives: Other: 0.9% Saline |
| TY027 20 mg/kg | Experimental | Subject will be administered with 20 mg/kg of TY027 via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo 20 mg/kg | Placebo comparator | Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. Receives: Other: 0.9% Saline |
| TY027 30 mg/kg | Experimental | Subject will be administered with 30 mg/kg of TY027 via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo 30 mg/kg | Placebo comparator | Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. Receives: Other: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
Measured: 84 Days
Secondary outcomes (7)
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 TY027 in human serum.
Measured: 84 Days
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 TY027 in human serum
Measured: 84 Days
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 TY027.
Measured: 84 Days
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 TY027.
Measured: 84 Days
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 TY027 in human serum.
Measured: 84 Days
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 TY027 in human serum.
Measured: 84 Days
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 TY027 in human serum.
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start9 Jun 2020
- Primary completion19 Nov 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease-2019 (COVID-19)Studies 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
- Participants are assigned to either treatment or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tychan Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jenny Low, MBBS, Principal investigator, SingHealth Investigational Medicine Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429529
- Sponsor's protocol ID
- SCT-001
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04429529
- Acronym / sponsor ID
- SCT-001
- Conditions
- Coronavirus Disease-2019 (COVID-19)
- Keywords
- Coronavirus Disease-2019, COVID-19, SARS-CoV-2, Monoclonal Antibody, Infectious diseases, Phase 1 first in human study, Singapore
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tychan Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 12 Jun 2020 (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.
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic.
To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Detailed description
This is a Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers.
Safety, tolerability and PK of TY027 will be assessed. The dose escalation will include 32 healthy volunteers across five (5) dose cohorts:
- 0.5 mg/kg, N = 2 TY027 + 2 Placebos
- 5 mg/kg, N = 5 TY027 + 2 Placebos
- 10 mg/kg, N = 5 TY027 + 2 Placebos
- 20 mg/kg, N = 5 TY027 + 2 Placebos
- 30 mg/kg, N = 5 TY027 + 2 Placebos
Subjects will be required to be inpatient at the trial site for approximately 24 hours.
A minimum of 20-hour interval from the first two (2) subjects dosing (1 treatment and 1 placebo concurrently) must take place before the third subject can be dosed within the cohort. No such time interval will be required for dosing of subsequent subjects (fourth subject onwards) within the same dose cohort.
After 24 hours, subjects will be discharged from the trial site and to return for scheduled follow-up visits. Subjects will be followed for up to approximately Day 84 with serum samples taken at specified times as per outlines in Table 1.
Dose escalations will be guided by a safety review of clinical signs, adverse events (AEs), laboratory tests (excluding lipase) and immune gene expression data of the prior dose cohort (up to 72 hours post-dose). Subsequent post-trial monitoring through weekly telephone calls will continue from Day 85 onwards for another three (3) more months.
Decisions not to dose escalate past any proposed dose level due to safety findings will not constitute a protocol violation.
Safety summaries (up to Day 3 post-dose) will be generated for each dose cohort and delivered to the Dose Escalation Review Committee (DERC) for review.
Interim analysis will be performed after Day 14 post-dose for each dose cohort and delivered to the Data Safety Monitoring Board (DSMB) for review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- Participants are assigned to either treatment or placebo
| Arm | Type | Receives |
|---|---|---|
| TY027 0.5 mg/kg | Experimental | Biological: TY027Subject will be administered with 0.5 mg/kg of TY027 via IV infusion over a period of 30 minutes. |
| Placebo 0.5 mg/kg | Placebo comparator | Other: 0.9% SalineSubject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. |
| TY027 5mg/kg | Experimental | Biological: TY027Subject will be administered with 5 mg/kg of TY027 via IV infusion over a period of 30 minutes. |
| Placebo 5 mg/kg | Placebo comparator | Other: 0.9% SalineSubject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. |
| TY027 10 mg/kg | Experimental | Biological: TY027Subject will be administered with 10 mg/kg of TY027 via IV infusion over a period of 30 minutes. |
| Placebo 10 mg/kg | Placebo comparator | Other: 0.9% SalineSubject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. |
| TY027 20 mg/kg | Experimental | Biological: TY027Subject will be administered with 20 mg/kg of TY027 via IV infusion over a period of 30 minutes. |
| Placebo 20 mg/kg | Placebo comparator | Other: 0.9% SalineSubject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. |
| TY027 30 mg/kg | Experimental | Biological: TY027Subject will be administered with 30 mg/kg of TY027 via IV infusion over a period of 30 minutes. |
| Placebo 30 mg/kg | Placebo comparator | Other: 0.9% SalineSubject will be administered with 0.9% saline via IV infusion over a period of 30 minutes. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult volunteers, aged 21 to 50 years old, men or women
- Subjects negative for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus surface Antigen (HBsAg) and Hepatitis C virus (HCV antibody screen)
- Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and make themselves available for the duration of the study with access to a consistent means of telephone contact, which may be, but not limited to, at home or at work via landline or mobile
- 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 a stable health status. Normal laboratory values must be within normal range of the assessing site or show minor variations that are deemed not clinically significant as judged by the Investigator and acceptable for study entry. A stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event
Key exclusion criteria (12 listed)
- Subject previously diagnosed with COVID-19 or had been issued with a quarantine order by the Ministry of Health
- Presence of acute infection in the preceding 14 days, or presence of a temperature ≥ 38.0 ˚C (oral or tympanic temperature assessment), or acute symptoms of any severity on the scheduled date of admission
- History of severe drug and / or food allergies and / or known allergies to the trial product or its components
- Female subject who is pregnant or breast-feeding
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, or immunosuppressive disorders
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 |
|---|---|---|
| TY027TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) | Biological | TY027 0.5 mg/kg, TY027 10 mg/kg, TY027 20 mg/kg, TY027 30 mg/kg, TY027 5mg/kg |
| 0.9% SalinePlacebo | Other | Placebo 0.5 mg/kg, Placebo 10 mg/kg, Placebo 20 mg/kg, Placebo 30 mg/kg, Placebo 5 mg/kg |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 84 Days
To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
7 secondary outcomes
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Time frame: 84 Days
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Time frame: 84 Days
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
Time frame: 84 Days
AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
Time frame: 84 Days
Half-Life (t1/2) - Pharmacokinetic Assessment
Time frame: 84 Days
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Time frame: 84 Days
Clearance [CL] - Pharmacokinetic Assessment
Time frame: 84 Days
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 8 Apr 2021.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 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.
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 TY027 and 0.9% Saline in people with Coronavirus Disease-2019 (COVID-19), 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 12 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 8 Apr 2021. 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. 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 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 84 Days). 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 NCT04429529, which also lists 1 linked publication.
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 8 Apr 2021.