Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BDHK-2009 Tablets in Healthy Adults: Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study
Led by Benethera (Shaoxing) Biotechnology Co., Ltd. · Updated on 2026-06-08
68
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, two-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of BDHK-2009 tablets in healthy adult participants. This first-in-human trial aims to assess single ascending oral doses and multiple oral doses of BDHK-2009 in adults aged 18 to 55 years. The study is sponsored by Benethera (Shaoxing) Biotechnology Co., Ltd. and focuses on gathering initial safety and drug behavior data in the body. Participants will be assigned randomly to receive either BDHK-2009 tablets or placebo. In Part 1 (SAD), participants receive a single dose of the study drug or placebo, including a special cross-over period to assess the effect of a high-fat meal on the drug's pharmacokinetics. Part 2 (MAD) involves multiple ascending doses with three cohorts of eight healthy subjects each, randomized in a 3:1 ratio to receive BDHK-2009 or placebo once daily. Treatments are given orally, and the study includes a placebo comparator group. During the study, participants will undergo physical exams, vital sign checks, ECGs, and laboratory tests to monitor safety and drug effects from enrollment until four weeks after treatment begins. Researchers will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of BDHK-2009, including the impact of food intake on drug absorption. The study requires adherence to visit schedules and monitoring to ensure participant safety and accurate data collection.
CONDITIONS
Brief Title
A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate effectively and comply with the trial requirements, and willing to sign informed consent
- Healthy adults aged 18 to 55 years, any gender
- Weight at least 50 kg for males and 45 kg for females, with BMI between 18 and 26 kg/m²
- Normal or non-clinically significant results on physical exam, vital signs, ECG, and lab tests at screening
- Women of childbearing potential must have negative pregnancy tests and agree to use contraception during and at least 90 days after treatment
- Male participants with partners of childbearing potential must agree to use contraception and abstain from sperm donation during and 90 days after treatment
You will not qualify if you...
- Known or persistent psychiatric disorders requiring medication that interfere with participation
- Significant abnormalities or diseases in major organs or systems as judged by investigator
- Active or suspected active infections, including recent or recurrent infections
- History of epidemic meningococcal infection, splenectomy, or functional asplenia
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History or evidence of active or latent tuberculosis
- History of multiple allergies or hypersensitivity to study drug or related drugs
- Participation in other interventional studies within 30 days or 5 half-lives of other study drugs
- Drug abuse within 12 months or positive drug screening
- Use of strong CYP3A enzyme inducers or inhibitors within 14 days prior to dosing
- Use of prescription or over-the-counter medications within 14 or 7 days prior to dosing unless approved
- Consumption of certain foods or beverages affecting liver enzymes before dosing
- Excessive alcohol use or positive alcohol screening
- Heavy smoking or inability to abstain from tobacco/nicotine products
- Recent significant blood loss or donation
- Clinically significant ECG abnormalities
- Dysphagia or special dietary needs preventing standard diet
- Major surgery within 3 months prior or planned during study
- Vaccination within 8 weeks prior or planned during or 8 weeks after dosing
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive BDHK-2009 Tablets or placebo in single and multiple dose periods to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits during single and multiple dose periods
Trial Site Locations
Total: 1 location
1
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China, 311200
Actively Recruiting
Research Team
S
Shuang Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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