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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05635084
Registration number
NCT05635084
Ethics application status
Date submitted
20/10/2022
Date registered
2/12/2022
Date last updated
17/01/2024
Titles & IDs
Public title
A First-in-human Study of YN001 in Healthy Volunteers
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Scientific 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
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Secondary ID [1]
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YN001-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - YN001
Treatment: Drugs - Placebo for YN001
Experimental: YN001 - 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.
Placebo Comparator: Matching placebo for YN001 - 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.
Treatment: Drugs: YN001
Dose ranges from 2-90mg
Treatment: Drugs: Placebo for YN001
5% dextrose injection to mimic the YN001
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The safety and tolerability of intravenously administered YN001 in healthy subjects.
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 15 days of last dose
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Secondary outcome [1]
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Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration (AUC0-t)
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Assessment method [1]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [1]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [2]
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Area under the plasma concentration-time curve to infinity(AUCinf)
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Assessment method [2]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [2]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [3]
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Maximum plasma concentration(Cmax)
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Assessment method [3]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [3]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [4]
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Time of maximum concentration (Tmax)
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Assessment method [4]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [4]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [5]
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Clearance(CL)
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Assessment method [5]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [5]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [6]
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Elimination half-life (t1/2)
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Assessment method [6]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [6]
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Up to 168 hours of post initiation of last dose
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Secondary outcome [7]
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Volume of distribution estimates (Vdss)
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Assessment method [7]
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To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Timepoint [7]
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Up to 168 hours of post initiation of last dose
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Eligibility
Key inclusion criteria
1. Written informed consent must be obtained before any assessment is performed.
2. 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.
3. 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.
4. Weigh at least 50 kg, and have a body mass index (BMI) within the rage of 18-32 kg/m2.
5. Willing and able to comply with the requirements of the study.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Subjects fulfilling any of the following criteria are not eligible for inclusion in this
study.
1. 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.
2. 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.
3. Fasting triglyceride concentration >2.8 mmol/L.
4. A history of clinically significant ECG abnormalities, or any of the following ECG
abnormalities at Screening or Baseline:
- PR > 220 msec
- QRS complex > 120 msec
- QTcB > 450 msec (males)
- QTcB > 470 msec (females)
5. Pregnant or nursing (lactating) women.
6. 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.
7. 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.
8. 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.
9. A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or
human immunodeficiency virus (HIV) test result.
10. A positive COVID-19 test result.
11. 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).
12. Multiple drug allergies, or history of allergic reactions to rosuvastatin or any
components of the study drug.
13. Donation or loss of more than 400 mL of blood within 3 months prior to study drug
administration.
14. Plasma donation (> 100 ml) within 60 days prior to first dosing.
15. Hemoglobin levels below 12.0 g/dl at screening.
16. Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction
(e.g., recurrent episodes of fainting, palpitations, etc.).
17. 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.
18. History of significant food allergies (e.g. anaphylactic reactions). Mild
(non-anaphylactic, hypersensitivity) food allergies such as lactose
intolerance/glucose intolerance are permitted.
19. 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), ?-GT, alkaline phosphatase, or serum bilirubin. The
Investigator should be guided by the following criteria:
- Any single parameter of ALT, AST, ?-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, ?-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.
20. Significant illness resolved within two (2) weeks prior to initial dosing.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/04/2024
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Actual
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Sample size
Target
89
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Beijing Inno Medicine Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This will be a single center, randomized, double-blind, placebo-controlled, single ascending
dose and multiple ascending dose study in healthy adult subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05635084
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ofer Gonen, Ph.D
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Address
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Nucleus Network Pty Ltd.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jamie Zhang, Master
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Address
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Country
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Phone
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01082599080
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05635084
Download to PDF