Actively Recruiting
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2025-10-03
66
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis. Part 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults. Dose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.
CONDITIONS
Official 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...
- Voluntary informed consent and ability to comply with study and communication requirements
- Healthy adults aged 18 to 45 years at screening
- Body mass index between 19.0 and 26.0 kg/m²
- Minimum weight of 50 kg for males or 45 kg for females
- Normal or clinically insignificant vital signs, physical exam, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results
- Agreement to use effective non-drug contraception from consent until 90 days after last dose with no plans for sperm or egg donation during this period
You will not qualify if you...
- Pregnant or breastfeeding women, positive pregnancy test, or unprotected sex within 2 weeks before dosing
- History or presence of significant disorders affecting safety or participation
- Use of drugs affecting liver metabolism within 4 weeks or any medication within 2 weeks before dosing, or planned use during trial
- Major surgery within 3 months before screening or planned during trial
- History of fever or active infection within 2 weeks before screening
- Blood loss or donation over 400 mL within 3 months before screening or planned donation during or within 30 days after trial
- History of significant food or drug allergies, or allergy to JKN2501/excipients
- Excessive alcohol use or inability to abstain from alcohol from 48 hours before dose until end of study
- Smoking 5 or more cigarettes per day 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 this trial
- Estimated glomerular filtration rate less than 90 mL/min
- Serum total calcium below normal at screening
- Unsuitable venous access or history of adverse reactions to infusion or blood draws
- Excessive intake of tea, coffee, or caffeinated beverages within 3 months before screening
- Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods/beverages within 48 hours before first dose or inability to abstain during trial
- History of QTc prolongation or clinically significant ECG abnormalities
- Any other condition making the participant unsuitable as determined by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Third hospital of Changsha
Changsha, Hunan, China, 410035
Actively Recruiting
Research Team
Y
Yin Yang
CONTACT
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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