Cardiovascular DiseasesPhase 1NCT05635084
A First-in-human Study of YN001 in Healthy Volunteers
A Phase 1 study testing YN001 in people with Cardiovascular Diseases, run by Beijing Inno Medicine Co., Ltd. at 1 site in Australia.
Trial summary
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- YN001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Dec 2022to 9 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Healthy male and female adults aged from 18 to 55 Years of age included, and in good health as determined by past medical history, physical examination, and vital signs, electrocardiogram, and laboratory tests at screening.
- At screening, and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3) minutes.
- Weigh at least 50 kg, and have a body mass index (BMI) within the rage of 18-32 kg/m2.
- Willing and able to comply with the requirements of the study.
Who cannot join
- Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
- Receiving an investigational agent at the time of enrollment, or within 30 days or 5 half-lifes of enrollment, whichever is longer prior to study drug administration.
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, COVID-19 vaccine, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed, (i.e., an incidental and limited need of maximum 2 g per day, no more than 3 consecutive days within 2 weeks prior to dosing) paracetamol is acceptable, but must be documented in the Concomitant medications page of the CRF.
- Fasting triglyceride concentration >2.8 mmol/L.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at Screening or Baseline:
- PR > 220 msec
Show all 33Show fewer
- QRS complex > 120 msec
- QTcB > 450 msec (males)
- QTcB > 470 msec (females)
- Pregnant or nursing (lactating) women.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant UNLESS the subject agrees to comply with highly effective, double barrier contraception for the entire duration of the study and for a period of 30 days after the dose of study drug. Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS the subject agrees to comply with highly effective, double barrier contraception for the entire duration of the study and for a period of 30 days after the dose of study drug.
- Smokers (use of tobacco products in the previous 1 month). Urine cotinine levels will be measured during screening and at baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. For light smokers to pass the cotinine test, smoking should be stopped at least 24 hours prior to reporting to the center (i.e., Day -2, early morning). Smoking will not be allowed during the study.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays for alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates conducted during screening and/or baseline. Any THC-containing products should not be used at least 7 days prior to screening, and participant needs to abstain any THC-containing products during the trial. Alcohol abuse was defined as consumption of 14 or more standard drinks per week.
- A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test result.
- A positive COVID-19 test result.
- History of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis (e.g., hypothyroidism, family history of hereditary myopathy, previous muscle toxicity with HMG-CoA reductase inhibitors or fibrates).
- Multiple drug allergies, or history of allergic reactions to rosuvastatin or any components of the study drug.
- Donation or loss of more than 400 mL of blood within 3 months prior to study drug administration.
- Plasma donation (> 100 ml) within 60 days prior to first dosing.
- Hemoglobin levels below 12.0 g/dl at screening.
- Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
- Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), or cardiac dysfunction or myocardial infarction.
- History of significant food allergies (e.g. anaphylactic reactions). Mild (non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance/glucose intolerance are permitted.
- Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical or laboratory evidence of any of the following:
- Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding in the last 6 months;
- Pancreatic injury or pancreatitis in the last 6 months;
- Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria:
- Any single parameter of ALT, AST, γ-GT, alkaline phosphatase, or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN).
- Any elevation above ULN of more than one parameter of ALT, AST, γ-GT, alkaline phosphatase, or serum bilirubin excludes a subject from participation in the study.
- If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
- History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria).
- Evidence of urinary obstruction or difficulty in voiding at screening.
- Significant illness resolved within two (2) weeks prior to initial dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered YN001 in Healthy Subjects
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
Read the detailed description
A total of approximately 73 to 89 healthy male and female subjects will be enrolled into this study, it includes two parts:
Part A is single ascending dose stage, approximately 49 to 65 healthy subjects will be enrolled into about eight to ten cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The doses will be progressively escalated, with a sentinel dosing strategy employed for all cohorts.
Part B is multiple ascending dose stage, approximately 24 healthy subjects will be enrolled into about three cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The cohort M1 will be initiated by decision of SRC(safety review committee), then the doses will be progressively escalated.
- Conditions
- Cardiovascular Diseases
- Being tested
- YN001, Placebo for YN001
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YN001Drug
Dose ranges from 2-90mg
Placebo for YN001Drug
Also called YN001
5% dextrose injection to mimic the YN001
| Study group | Role | What they receive |
|---|---|---|
| YN001 | Experimental | YN001 (with a strength of 5 mL:10 mg). Subjects will be administered 250 to 500 mL of YN001 diluted in 5% dextrose injection up to 120 min(which allows a +/-5 min infusion window) intravenous infusion. Receives: Drug: YN001 |
| Matching placebo for YN001 | Placebo comparator | Matching placebo for YN001 is 5% dextrose injection. Subjects will be administered 250 to 500mL of 5% dextrose injection up to 120 min (which allows a +/-5 min infusion window) intravenous infusion. Receives: Drug: Placebo for YN001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of intravenously administered YN001 in healthy subjects.
To evaluate the incidence of Adverse Events as Assessed by CTCAE v5.0, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities, Clinically Significant Physical Examination Abnormalities and Infusion Reaction.
Measured: Up to 15 days of last dose
Secondary outcomes (8)
Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration (AUC0-t)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Area under the plasma concentration-time curve to infinity(AUCinf)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Maximum plasma concentration(Cmax)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Clearance(CL)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Volume of distribution estimates (Vdss)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Immunogenicity
To evaluate the immunogenicity YN001 in healthy subjects.
Measured: Up to 168 hours of post initiation of last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start16 Dec 2022
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ofer Gonen, Ph.D, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635084
- Sponsor's protocol ID
- YN001-001
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered YN001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05635084
- Acronym / sponsor ID
- YN001-001
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 2 Dec 2022 (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.
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
Detailed description
A total of approximately 73 to 89 healthy male and female subjects will be enrolled into this study, it includes two parts:
Part A is single ascending dose stage, approximately 49 to 65 healthy subjects will be enrolled into about eight to ten cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The doses will be progressively escalated, with a sentinel dosing strategy employed for all cohorts.
Part B is multiple ascending dose stage, approximately 24 healthy subjects will be enrolled into about three cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The cohort M1 will be initiated by decision of SRC(safety review committee), then the doses will be progressively escalated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YN001 | Experimental | Drug: YN001YN001 (with a strength of 5 mL:10 mg). Subjects will be administered 250 to 500 mL of YN001 diluted in 5% dextrose injection up to 120 min(which allows a +/-5 min infusion window) intravenous infusion. |
| Matching placebo for YN001 | Placebo comparator | Drug: Placebo for YN001Matching placebo for YN001 is 5% dextrose injection. Subjects will be administered 250 to 500mL of 5% dextrose injection up to 120 min (which allows a +/-5 min infusion window) intravenous infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained before any assessment is performed.
- Healthy male and female adults aged from 18 to 55 Years of age included, and in good health as determined by past medical history, physical examination, and vital signs, electrocardiogram, and laboratory tests at screening.
- At screening, and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3) minutes.
- Weigh at least 50 kg, and have a body mass index (BMI) within the rage of 18-32 kg/m2.
- Willing and able to comply with the requirements of the study.
Key exclusion criteria (33 listed)
- Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
- Receiving an investigational agent at the time of enrollment, or within 30 days or 5 half-lifes of enrollment, whichever is longer prior to study drug administration.
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, COVID-19 vaccine, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed, (i.e., an incidental and limited need of maximum 2 g per day, no more than 3 consecutive days within 2 weeks prior to dosing) paracetamol is acceptable, but must be documented in the Concomitant medications page of the CRF.
- Fasting triglyceride concentration >2.8 mmol/L.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at Screening or Baseline:
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 |
|---|---|---|
| YN001Dose ranges from 2-90mg | Drug | YN001 |
| Placebo for YN001Also: YN0015% dextrose injection to mimic the YN001 | Drug | Matching placebo for YN001 |
Primary outcome
The safety and tolerability of intravenously administered YN001 in healthy subjects.
Time frame: Up to 15 days of last dose
To evaluate the incidence of Adverse Events as Assessed by CTCAE v5.0, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities, Clinically Significant Physical Examination Abnormalities and Infusion Reaction.
8 secondary outcomes
Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration (AUC0-t)
Time frame: Up to 168 hours of post initiation of last dose
Area under the plasma concentration-time curve to infinity(AUCinf)
Time frame: Up to 168 hours of post initiation of last dose
Maximum plasma concentration(Cmax)
Time frame: Up to 168 hours of post initiation of last dose
Time of maximum concentration (Tmax)
Time frame: Up to 168 hours of post initiation of last dose
Clearance(CL)
Time frame: Up to 168 hours of post initiation of last dose
Elimination half-life (t1/2)
Time frame: Up to 168 hours of post initiation of last dose
Volume of distribution estimates (Vdss)
Time frame: Up to 168 hours of post initiation of last dose
Immunogenicity
Time frame: Up to 168 hours of post initiation of last dose
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 18 Nov 2024.
- 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.
Ofer Gonen, Ph.D principal investigator
Nucleus Network Pty 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 YN001 in people with Cardiovascular Diseases, run by Beijing Inno Medicine Co., 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 5 inclusion and 33 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 18 Nov 2024. 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?
The safety and tolerability of intravenously administered YN001 in healthy subjects. (time frame: Up to 15 days of last dose). 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 18 Nov 2024.