A Phase 1 interventional study of NYR-BI03 and Matching placebo (all cohorts) in Healthy, sponsored by Nyrada Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Nyrada Pty Ltd · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to learn if investigational drug NYR-BI03 is safe and tolerated when given as an intravenous infusion for up to 6 hours to healthy male and female volunteers.
The study will also show what if any medical problems participants have when taking drug NYR-BI03 and it will provide information on blood levels of the drug.
Researchers will compare drug NYR-BI03 to a placebo (a similar substance that contains no drug) to see if NYR-BI03 is safe and tolerated.
Participants will be administered drug NYR-BI03 or a placebo via intravenous infusion for up to 6 hours and be assessed by physical examination and laboratory tests.
The study is a Phase 1, double-blind, randomised, first-in-human, dose escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of NYR-BI03 when administered as an intravenous (IV) infusion for up to 6 hours to healthy participants.
Six (6) ascending dose cohorts are planned. Up to 48 participants will be enrolled sequentially into the cohorts, with a total of 8 participants per cohort (6 active, 2 placebo).
Each participant will be screened within a 28-day screening period after providing voluntary, written informed consent. If eligible, participants will be admitted to the clinical unit on Day -1 for confinement and randomised to be administered a single IV dose of NYR-BI03 or placebo for up to 6 hours on Day 1.
After confinement for at least 48 hours after the start of infusion for safety assessments and collection of PK blood samples, participants will be discharged from the clinical unit on Day 3. Participants will return to the clinical unit for the End of Study visit (EOS) on Day 7 for final safety monitoring.
Safety assessments will include collection of adverse events (AEs), laboratory tests (hematology, biochemistry, coagulation, urinalysis), physical examination, basic neurological examination, pupillary response assessment, vital signs, cardiac telemetry, and 12-lead electrocardiogram (ECG). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed at least 24 hours before the rest of the cohort.
Blinded safety and tolerability data from the sentinel group up to and including 24 hours post-dose (i.e., up to and including the Day 2 assessments) will be reviewed by the Principal Investigator, with provision for additional review if deemed necessary. Following a satisfactory safety review, dosing of the rest of the cohort may proceed.
After each completed dose cohort, the Safety Review Committee (SRC) will review the available cumulative blinded safety data and available blinded PK data.
Nyrada Pty Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYR-BI03 administered in escalating doses as a continuous intravenous infusion for up to 6 hours
Drug: NYR-BI03
Placebo comparator administered as a continuous intravenous infusion for up to 6 hours
Drug: Matching placebo (all cohorts)
Participants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours or 6 hours.
Also known as: Xolatryp
Administered as a continuous intravenous infusion over 3 hours or 6 hours
Number of Participants with Treatment-Related Adverse Events
The safety and tolerability of NYR-BI03 in healthy volunteers, when administered as a 3 hour or 6 hour intravenous (IV) infusion.
Time frame: From enrollment up to and including follow-up assessments on Day 7
Area under the plasma concentration versus time curve (AUC) of NYR-BI03
Blood samples taken at regular intervals pre and post the start of infusion
Time frame: For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.
Maximum observed blood concentration (Cmax) of NYR-BI03
Blood samples taken at regular intervals pre and post the start of infusion
Time frame: For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.
Tmax (time of occurrence of Cmax) of NYR-BI03
Blood samples taken at regular intervals pre and post the start of infusion
Time frame: For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.
Apparent terminal half-life (T1/2) of NYR-BI03
Blood samples taken at regular intervals pre and post the start of infusion
Time frame: For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.
Total body clearance from blood (CL) of NYR-BI03 calculated as Dose/AUC
Blood samples taken at regular intervals pre and post the start of infusion
Time frame: For 3-hour infusion: Pre-infusion, +10minutes, +30 minutes, 1, 2, 3, 3.5, 4, 6 , 9 hours. For 6-hour infusion: Pre-infusion, +10minutes, +30 minutes and 1, 3, 4, 6, 6.5, 7, 9, 12, 24 hours.
Plan to share: Yes — We will share de-identified individual participant data along with key supporting documents (protocol, statistical analysis plan, data dictionary, clinical study report, and case report forms).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available 12 months after publication of primary results and remain accessible for at least 5 years.
Access criteria: Data access requests will be evaluated by an independent Data Access Committee. Applicants must submit a research proposal and evidence of ethics approval, and, if approved, sign a data use agreement that restricts use to the proposed research and prohibits re-identification. Data will be hosted in a secure repository. For inquiries, please contact Dr Alexandra Suchowerska at alexandra.suchowerska@nyrada.com
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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