A First-in-human Study of YN001 in Healthy Volunteers

NCT05635084 | Completed Phase 1

• 1 other identifier: YN001-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Up to 168 hours of post initiation of last dose

• Area under the plasma concentration-time curve to infinity(AUCinf)

  Up to 168 hours of post initiation of last dose

• Maximum plasma concentration(Cmax)

  Up to 168 hours of post initiation of last dose

• Time of maximum concentration (Tmax)

  Up to 168 hours of post initiation of last dose

• Clearance(CL)

  Up to 168 hours of post initiation of last dose

Study Arms (2)

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.

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.

Drug: Placebo for YN001

Interventions

YN001 DRUG

Dose ranges from 2-90mg

YN001

Placebo for YN001 DRUG

5% dextrose injection to mimic the YN001

Also known as: YN001

Matching placebo for YN001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Beijing Inno Medicine Co., Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ofer Gonen, Ph.D

  Nucleus Network Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 2, 2022
• Study Start: December 16, 2022
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)