New antibiotic JKN2501 enters first human tests
NCT ID NCT07207291
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests the safety and tolerability of a new antibiotic called JKN2501 in 66 healthy adults in China. Participants receive either the drug or a placebo by IV infusion, and researchers monitor for side effects and how the drug moves through the body. The goal is to see if it is safe enough to study further for treating bacterial infections like urinary tract, abdominal, and respiratory infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JKN2501 (an experimental antibiotic given by IV infusion)
- What this could lead to
- If safe, this could lead to a new antibiotic for bacterial infections that are hard to treat.
- What could go wrong
- This is a very early Phase 1 trial in only 66 healthy people, so it is not yet tested in patients. The drug may cause side effects or fail in later studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary informed consent; able to comply with study requirements and communicate effectively. * Healthy subjects 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. Exclusion Criteria: * 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 interventional 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Third hospital of Changsha
RECRUITINGChangsha, Hunan, 410035, China
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