Actively Recruiting
Phase I Randomized, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 in Healthy Chinese Adults
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2025-10-03
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to study the safety, tolerability, and pharmacokinetics of JKN2501, an intravenous drug, in healthy Chinese adults aged 18 to 45 years. The trial is randomized, double-blind, placebo-controlled, and involves dose escalation to assess how the drug behaves in the body and its possible side effects. The study has two parts: the first part tests single ascending doses of JKN2501, while the second part examines multiple ascending doses. Dose levels may be adjusted based on safety and pharmacokinetic data from earlier groups. Participants receive the drug or placebo through intravenous infusion in various dose groups. Participants will be monitored closely through physical exams, vital signs, ECGs, lab tests, chest X-rays, and ultrasounds. Biological samples such as blood, urine, and feces will be collected for pharmacokinetic analysis. Safety and tolerability will be evaluated from baseline to specific days after dosing. The study includes adherence to contraception guidelines and careful safety monitoring throughout the trial, with participation lasting several days depending on the study part.
CONDITIONS
Brief Title
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and can comply with study requirements
- Healthy adults aged 18 to 45 years at screening
- Body mass index between 19.0 and 26.0 kg/m�b2
- Weight �b550 kg for males or �b545 kg for females
- Normal or clinically insignificant vital signs, physical exam, ECG, lab tests, chest X-ray, and abdominal ultrasound
- Agree to use effective contraception from signing until 90 days after last dose and no plans for sperm or egg donation during this period
You will not qualify if you...
- Pregnant or breastfeeding women or positive pregnancy test
- Unprotected sex within 2 weeks before dosing
- Any clinically significant disorder affecting safety or participation as judged by investigator
- Use of drugs affecting liver metabolism within 4 weeks or any medication within 2 weeks before dosing
- Major surgery within 3 months before screening or planned during trial
- Recent febrile illness or active infection within 2 weeks before screening
- Blood donation over 400 mL within 3 months before screening or planned blood donation during or within 30 days after dosing
- History of significant food or drug allergy or allergy to JKN2501 or its ingredients
- Excessive alcohol use or inability to abstain from alcohol from 48 hours before dose until study end
- Smoking 5 or more cigarettes daily within 3 months before screening or inability to abstain from smoking from 48 hours before dose until study end
- History of drug abuse or positive drug screen at baseline
- Positive alcohol breath test at baseline
- Participation in another interventional clinical trial within 3 months before screening or planned during trial
- Estimated kidney function (eGFR) below 90 mL/min
- Low serum total calcium at screening
- Unsuitable venous access or history of infusion-related symptoms or phobias
- Excessive daily intake of tea, coffee, or caffeine-containing drinks within 3 months before screening
- Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods or drinks within 48 hours before first dose
- History of prolonged QTc or significant ECG abnormalities at screening
- 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 18 days depending on cohort assignment
Participants receive single or multiple intravenous (IV) infusions of JKN2501 or placebo to evaluate safety and pharmacokinetics.
1 baseline visit and multiple visits during dosing and follow-up
Trial Site Locations
Total: 1 location
1
The Third hospital of Changsha
Changsha, Hunan, China, 410035
Actively Recruiting
Research Team
Y
Yin Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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