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New treatment option for Bacterial Infections
Official title Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT07207291
What this study is testing
What is JKN2501?
JKN2501 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bacterial infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Voluntary informed consent; able to comply with study requirements and communicate effectively.
- Healthy people aged 18-45 years (inclusive) at screening.
- BMI 19.0-26.0 kg/m² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).
- Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant...
- Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm/egg donation plans during this...
You likely can't join if
- Pregnant/lactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.
- Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.
- Use of drugs known to inhibit/induce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior...
- Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.
- History of febrile illness or active infection within 2 weeks prior to screening.
- Blood loss/donation \>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days...
See the full eligibility criteria
- Voluntary informed consent; able to comply with study requirements and communicate effectively.
- Healthy people aged 18-45 years (inclusive) at screening.
- BMI 19.0-26.0 kg/m² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).
- Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.
- Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm/egg donation plans during this period.
- Pregnant/lactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.
- Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.
- Use of drugs known to inhibit/induce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.
- Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.
- History of febrile illness or active infection within 2 weeks prior to screening.
- Blood loss/donation \>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.
- History of significant food/drug allergy, or allergy to JKN2501/excipients.
- Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.
- Smoking ≥5 cigarettes/day within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.
- History of drug abuse; positive urine drug screen at baseline (Day -1).
- Positive alcohol breath test at baseline (Day -1).
- Participation in another treatment clinical trial within 3 months prior to screening or planned during this trial.
- Estimated glomerular filtration rate (eGFR) \<90 mL/min.
- Serum total calcium below lower limit of normal at screening.
- Investigator-determined unsuitable venous access for PK sampling/infusion, or history of adverse symptoms/phobias related to infusion/phlebotomy.
- Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.
- Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods/beverages within 48h prior to first dose; inability to abstain during the trial.
- History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening/baseline.
- Any other condition deemed by the investigator to make the subject unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.