Pharmacokinetics of YN001 in healthy adults

A Pharmacokinetic Study of YN001 in Healthy Participants

This study will test how a single dose of the experimental drug YN001 is processed in the bodies of healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Inno Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT07190885 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label, single-dose Phase 1 trial enrolling about 24 healthy adults split into two dose groups. Participants will undergo screening, a baseline visit, dosing on Day 1, and safety/PK/immunogenicity follow-up through Day 15 with an in-person assessment through Day 8 and a phone completion on Day 15. The trial collects blood and other standard safety measurements to define YN001's pharmacokinetic profile and monitor for adverse events. Results will be used to refine dosing and support further clinical development in patients.

Who should consider this trial

Good fit: Healthy men and women aged 18–65 with BMI 18–32 kg/m2, weighing at least 50 kg, meeting contraception and vital-sign requirements, and willing to attend all visits are ideal candidates.

Not a fit: People with health conditions, pregnant or breastfeeding individuals, minors, or those outside the specified age, weight, BMI, or vital-sign ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could establish safe dosing and timing information that helps design later trials that may benefit patients.

How similar studies have performed: Single-dose pharmacokinetic studies in healthy volunteers are a routine and well-established early step that have informed dosing for many drugs, though YN001 itself remains untested in patients.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Healthy male and female adults aged from 18 to 65 years of age (inclusive) at time of Screening, and in good health as determined by no clinically significant (as judged by the PI/delegate) past medical history, physical examination, and vital signs, electrocardiogram (ECG), and laboratory tests at Screening and Baseline (Day -1).
3. Vital signs (systolic and diastolic blood pressure and pulse rate) measurements within the below ranges at Screening and Baseline (Day -1):

   * tympanic body temperature between 35.5-37.7 °C
   * systolic blood pressure, 90-140 mm Hg (inclusive)
   * diastolic blood pressure, 40-95 mm Hg (inclusive)
   * pulse rate, 40-100 bpm (inclusive)
4. Weigh at least 50 kg and have a body mass index (BMI) within the range of 18-32 kg/m2 at Screening and Baseline (Day -1).
5. Meets contraception requirements.
6. Willing and able to comply with the study requirements and restrictions.

Exclusion Criteria:

1. Received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
2. Use of any prescription drugs, over the counter (OTC) medication, herbal supplements, dietary supplements (vitamins included), any type of vaccine within two weeks prior to the study drug administration, unless deemed acceptable by the Principal Investigator (or delegate) and agreement with the Sponsor.
3. Fasting triglyceride concentration \>2.8 mmol/L at Screening or Baseline (Day -1).
4. A history of clinically significant ECG abnormalities, or any ECG abnormalities at Screening or Baseline (Day -1).
5. Pregnant or nursing (lactating) women.
6. Average use of more than 5 cigarettes or equivalent nicotine containing products per week and/or unwilling to abstain from such products 7 days prior to study administration through until Day 15. Positive urine cotinine test at Baseline (Day -1); repeat testing may be permitted at PI/delegate discretion.
7. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by positive results for alcohol or drugs conducted at Screening and/or Baseline (Day -1). Alcohol abuse is defined as consumption of 14 or more standard drinks per week (where 1 unit = 375 mL of beer \[3.5% alc/vol\], 30 mL of 40% spirit or a 100 mL glass of wine \[13%\]). Any THC-containing products should not be used at least 7 days prior to Screening through until completion of Day 15.
8. A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test result at Screening.
9. 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).
10. Multiple drug allergies, or history of allergic reactions to study drug or any components of the study drug.
11. Donation or loss of more than 400 ml of blood within 3 months prior to study drug administration.
12. Plasma donation (\> 100 ml) within 60 days prior to first dosing.
13. Hemoglobin levels below 120 g/L at Screening or Baseline (Day -1).
14. Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
15. 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.
16. History of significant food allergies (e.g. anaphylactic reactions). Mild (non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance/glucose intolerance are permitted.
17. Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following:

    1. Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding in the last 6 months.
    2. Pancreatic injury or pancreatitis in the last 6 months.
    3. Liver disease or liver injury as indicated by abnormal liver function tests at Screening or Baseline (Day -1) such as SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase (ALP), or total bilirubin. The Investigator should be guided by the following criteria:

       • Any single parameter of ALT, AST, GGT, ALP, or total bilirubin must not exceed 1.5 x upper limit of normal (ULN).
    4. History or presence of impaired renal function as indicated by abnormal creatinine and/or urea values (e.g., eGFR\<90 mL/min/1.73 m2 (calculated by CKD-EPI equation), or abnormal urinary constituents (e.g., albuminuria), deemed clinically significant by the PI/delegate at Screening or Baseline (Day -1).
    5. Evidence of urinary obstruction or difficulty in voiding at Screening.
18. Significant illness resolved within two weeks prior to dosing, which may affect the study drug administration and safety assessments in the opinion of the PI/delegate.
19. Any other medical condition or social circumstance, which in the opinion of the PI/delegate would impede compliance with or hinder completion of the study or otherwise deem the participant unsuitable for inclusion.

Where this trial is running

Adelaide, South Australia

• CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Kerry Xu

Conditions Healthy Volunteers