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New antibiotic JKN2501 enters first human tests

NCT ID NCT07207291

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Third hospital of Changsha

    RECRUITING

    Changsha, Hunan, 410035, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.