Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Q: Who can participate in NCT07207291?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07207291?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers (NCT07207291) is a Phase 1 interventional studying Bacterial Infections and Urinary Tract Infections, sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Bacterial Infections, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 66 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Bacterial Infections subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary willing to sign a consent form; 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

JKN2501

Administration: Intravenous (IV) infusion.

DRUG

Placebo

0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Third hospital of Changsha

Changsha, Hunan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07207291), the sponsor (Joincare Pharmaceutical Group Industry Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07207291 clinical trial studying?

Who can participate in NCT07207291?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07207291?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07207291. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07207291. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.