Bacterial InfectionsPhase 1NCT07207291
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
A Phase 1 study testing JKN2501 in people with Bacterial Infections and Urinary Tract Infections, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections
- What is being tested?
- JKN2501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2025to 19 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third hospital of Changsha
Changsha, Hunan, 410035
Xin Li, M.D., 0731-85171341, cssdsyyllwyh@163.com
About this study
Official title: 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
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
- Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections, Respiratory Tract Infections
- Being tested
- JKN2501, Placebo
- Keywords
- Bacterial Infections
- Medical subject headings
- Bacterial Infections, Urinary Tract Infections, Intraabdominal Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKN2501Drug
Administration: Intravenous (IV) infusion.
PlaceboDrug
0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort1 | Experimental | JKN2501 125mg only, without placebo. Receives: Drug: JKN2501 |
| SAD Cohort2 | Experimental | JKN2501 B mg Receives: Drug: JKN2501; Drug: Placebo |
| SAD Cohort3 | Experimental | JKN2501 C mg Receives: Drug: JKN2501; Drug: Placebo |
| SAD Cohort4 | Experimental | JKN2501 D mg Receives: Drug: JKN2501; Drug: Placebo |
| SAD Cohort5 | Experimental | JKN2501 E mg Receives: Drug: JKN2501; Drug: Placebo |
| MAD Cohort1 | Experimental | JKN2501 F mg Receives: Drug: JKN2501; Drug: Placebo |
| MAD Cohort2 | Experimental | JKN2501 G mg Receives: Drug: JKN2501; Drug: Placebo |
| MAD Cohort3 | Experimental | JKN2501 H mg Receives: Drug: JKN2501; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of JKN2501 for Injection in healthy adults.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Secondary outcomes (6)
Pharmacokinetic parameter of JKN2501: Tmax
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: Cmax
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: t1/2
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: AUC0-t
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: AUC0-∞
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: CL
Measured: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start22 Aug 2025
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207291
- Sponsor's protocol ID
- JKN2501-I-01
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07207291
- Acronym / sponsor ID
- JKN2501-I-01
- Conditions
- Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections, Respiratory Tract Infections
- Keywords
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Mar 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort1 | Experimental | Drug: JKN2501JKN2501 125mg only, without placebo. |
| SAD Cohort2 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 B mg |
| SAD Cohort3 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 C mg |
| SAD Cohort4 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 D mg |
| SAD Cohort5 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 E mg |
| MAD Cohort1 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 F mg |
| MAD Cohort2 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 G mg |
| MAD Cohort3 | Experimental | Drug: JKN2501, Drug: PlaceboJKN2501 H mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JKN2501Administration: Intravenous (IV) infusion. | Drug | MAD Cohort1, MAD Cohort2, MAD Cohort3, SAD Cohort1, SAD Cohort2, SAD Cohort3, SAD Cohort4, SAD Cohort5 |
| Placebo0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion. | Drug | MAD Cohort1, MAD Cohort2, MAD Cohort3, SAD Cohort2, SAD Cohort3, SAD Cohort4, SAD Cohort5 |
Primary outcome
To evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of JKN2501 for Injection in healthy adults.
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
6 secondary outcomes
Pharmacokinetic parameter of JKN2501: Tmax
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: Cmax
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: t1/2
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: AUC0-t
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: AUC0-∞
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Pharmacokinetic parameter of JKN2501: CL
Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JKN2501 in people with Bacterial Infections and Urinary Tract Infections, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Yang (+86-0755-33268688, overseas@joincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of JKN2501 for Injection in healthy adults. (time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.