HealthyPhase 1NCT06894862
A Study of the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants
A Phase 1 study testing NYR-BI03 in people with Healthy, run by Nyrada Pty Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NYR-BI03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Mar 2025to 25 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female
- 50.0 to 105.0 kg (inclusive)
- Body Mass Index (BMI) BMI of 18.0 to 30.0 kg/m2 (inclusive)
- General Health Healthy, determined by a medical history
- Contraceptive Status: Must agree to use of established highly effective contraception for the duration of the study and for at least 30 days thereafter
- Venous Access in their left and right arm to allow collection of blood samples and drug administration.
Who cannot join
- Pregnant females and lactating females are excluded from participating in the study.
- History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
- History of severe allergy or anaphylaxis.
- A known hypersensitivity to any surgical dressing which may be used
- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, gynecological, ear, nose, and throat, or musculoskeletal disorders, psychiatric disorder or haematological disorders
- Any history of uncontrolled, severe asthma during the last 5 years
Show all 24Show fewer
- A creatinine clearance of less than 80 mL/min
- Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product.
- History of abnormal bleeding tendencies, clotting disorders or thrombophlebitis unrelated to venipuncture or intravenous cannulation
- A positive test for hepatitis B surface antigen, a history of hepatitis C without a negative polymerase chain reaction (PCR) test, a history of HIV infection or demonstration of HIV antibodies
- Any evidence of organ dysfunction, or any clinically significant clinical laboratory value which, in the opinion of the Investigator would jeopardize the safety of the participant or impact on the validity of the study results,
- Liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) >1.5 x upper limit of normal
- Alcohol Use Those who may have difficulty abstaining from alcohol during the 48 hr prior to dose administration and until completion of the inpatient stay
- History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse
- Taking any prescription medications within 14 days prior to dose administration and/or likely to require prescription medication during the study
- Taking over-the-counter (OTC) medications or herbal supplements for 10 days prior to dose administration and/or likely to require or be unwilling to refrain from using OTC medications or herbal supplements during the study (with the exception of paracetamol, contraceptives, vitamin and other nutrient supplement use, at the discretion of the Investigator)
- Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g. coffee, tea, cola and chocolate) during the 24 hr prior to dose administration and whilst confined at the clinical study facility.
- Psychiatric Disorder History of any psychiatric illness which may impair the ability to provide written informed consent
- Protocol Compliance: Poor compliers or those unlikely to attend.
- Recent Study Participation Receipt of any drug as part of a research study within 30 days or 5 half-lives, whichever is longer, of initial dose administration in this study
- Standard blood donation within the 12-week period before dose administration
- Unusual dietary habits and excessive or unusual vitamin intakes
- Vaccination or immunizations within 30 days of initial dose administration
- Participants with a risk of QT/ corrected QT interval (QTc) prolongation, namely: a. A marked baseline prolongation of corrected QTcF interval >450 ms in males and >470 ms in females in two ECGs, or b. A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: A Phase I, Double-Blind, Placebo-Controlled, Randomised, First in Human, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants, When Administered as an Infusion for up to 6 Hours
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- NYR-BI03, Matching placebo (all cohorts)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYR-BI03Drug
Also called Xolatryp
Participants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours or 6 hours.
Matching placebo (all cohorts)Drug
Administered as a continuous intravenous infusion over 3 hours or 6 hours
| Study group | Role | What they receive |
|---|---|---|
| NYR-BI03 intravenous infusion | Experimental | NYR-BI03 administered in escalating doses as a continuous intravenous infusion for up to 6 hours Receives: Drug: NYR-BI03 |
| Placebo intravenous infusion | Placebo comparator | Placebo comparator administered as a continuous intravenous infusion for up to 6 hours Receives: Drug: Matching placebo (all cohorts) |
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
The safety and tolerability of NYR-BI03 in healthy volunteers, when administered as a 3 hour or 6 hour intravenous (IV) infusion.
Measured: From enrollment up to and including follow-up assessments on Day 7
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start19 Mar 2025
- Primary completion24 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Model description
- Groups of participants are assigned to receive either NYR-BI03 or placebo in a 6:2 ratio (n=8 per cohort). Participants receiving the placebo will be pooled. Doses are escalated in five groups/cohorts, subject to safety review by the Safety Review Committee.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nyrada Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Argent, MD, Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894862
- Sponsor's protocol ID
- NYR-BI03-01
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Placebo-Controlled, Randomised, First in Human, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NYR-BI03 in Healthy Participants, When Administered as an Infusion for up to 6 Hours
- ClinicalTrials.gov ID
- NCT06894862
- Acronym / sponsor ID
- NYR-BI03-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nyrada Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 25 Mar 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Groups of participants are assigned to receive either NYR-BI03 or placebo in a 6:2 ratio (n=8 per cohort). Participants receiving the placebo will be pooled. Doses are escalated in five groups/cohorts, subject to safety review by the Safety Review Committee.
| Arm | Type | Receives |
|---|---|---|
| NYR-BI03 intravenous infusion | Experimental | Drug: NYR-BI03NYR-BI03 administered in escalating doses as a continuous intravenous infusion for up to 6 hours |
| Placebo intravenous infusion | Placebo comparator | Drug: Matching placebo (all cohorts)Placebo comparator administered as a continuous intravenous infusion for up to 6 hours |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and Female
- 50.0 to 105.0 kg (inclusive)
- Body Mass Index (BMI) BMI of 18.0 to 30.0 kg/m2 (inclusive)
- General Health Healthy, determined by a medical history
- Contraceptive Status: Must agree to use of established highly effective contraception for the duration of the study and for at least 30 days thereafter
Key exclusion criteria (24 listed)
- Pregnant females and lactating females are excluded from participating in the study.
- History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
- History of severe allergy or anaphylaxis.
- A known hypersensitivity to any surgical dressing which may be used
- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, gynecological, ear, nose, and throat, or musculoskeletal disorders, psychiatric disorder or haematological 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 |
|---|---|---|
| NYR-BI03Also: XolatrypParticipants receive NYR-BI03 nanosuspension formulated for continuous intravenous infusion to be given over 3 hours or 6 hours. | Drug | NYR-BI03 intravenous infusion |
| Matching placebo (all cohorts)Administered as a continuous intravenous infusion over 3 hours or 6 hours | Drug | Placebo intravenous infusion |
Primary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: From enrollment up to and including follow-up assessments on Day 7
The safety and tolerability of NYR-BI03 in healthy volunteers, when administered as a 3 hour or 6 hour intravenous (IV) infusion.
5 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of NYR-BI03
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
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
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
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
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.
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 29 Jul 2025.
- Individual participant dataSharing planned: 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).
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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.
Christopher Argent, MD principal investigator
Scientia Clinical Research Ltd
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 NYR-BI03 in people with Healthy, run by Nyrada Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 (time frame: From enrollment up to and including follow-up assessments on Day 7). 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 29 Jul 2025.