Healthy Volunteers (HV)Phase 1NCT07618156
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers
A Phase 1 study testing KR25102 for Injection in people with Healthy Volunteers (HV), run by Jiangxi Kvvit Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo. Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV)
- What is being tested?
- KR25102 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Mar 2027
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);
- Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m² (inclusive of boundary values);
- Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures;
- Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;
- For groups requiring pain testing: willing to undergo pain tests and pass training; with no wounds or skin diseases on the skin at the pain-stimulated site;
- Participants fully understand the purpose, requirements and potential risks of this trial, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial and sign the written informed consent form.
Who cannot join
- Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator;
- Subjects with personal or family history of hereditary angioedema;
- Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;
- Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening.
- Subjects who have used any hepatic enzyme inhibitors/inducers within 1 month before dosing (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.).
- Subjects who have participated in any clinical trials with investigational drugs/devices within 3 months prior to screening, or plan to participate in other clinical trials during the study.
Show all 11Show fewer
- Subjects with a history of drug abuse or positive results in drug abuse screening;
- Subjects with clinically significant abnormal physical examination results at screening or baseline as judged by the investigator;
- Subjects with positive screening results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody;
- Subjects with cardiac diseases including but not limited to congenital long QT syndrome, torsades de pointes or risk factors for torsades de pointes (e.g., cardiac insufficiency, family history of long QT syndrome), those currently receiving Class IA anti-arrhythmic drugs (e.g., quinidine or procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone or sotalol) or other drugs known to affect QT interval, or those with Fridericia-corrected QT interval (QTcF) ≥ 450 ms (male), QTcF ≥ 460 ms (female), PR interval > 200 ms or QRS interval ≥ 120 ms at screening;
- Subjects who fail pain test training as judged by the investigator (only applicable to groups requiring pain testing).
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
The Third Xiangya Hospital, Central South University
Changsha, Hunan, 410006
Guoping Yang, 0731-88618938, ygp9880@163.com
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Adult Chinese Participants
Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.
Read the detailed description
This study adopts a single-center, randomized, double-blind, placebo-controlled parallel-group, dose-escalation design.
This single ascending dose (SAD) study is designed with six dose cohorts: 5 mg, 10 mg, 20 mg, 30 mg, 45 mg, and 60 mg. A total of 53 healthy adult participants are planned to be enrolled.
Three participants are planned for the 5 mg cohort, randomized in a 2:1 ratio of investigational product to placebo. Each of the remaining five dose cohorts will enroll 10 participants, randomized in an 8:2 ratio of investigational product to placebo.
For the multiple ascending dose (MAD) part, three dose cohorts (10 mg, 20 mg, and 30 mg) are planned. A total of 30 healthy adult participants will be enrolled, with 10 participants per cohort randomized in an 8:2 ratio of investigational product to placebo.Subjects will receive once daily administration for 7 consecutive days according to the randomization scheme.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- KR25102 for Injection, Placebo for KR25102 for Injection
- Keywords
- KR25102, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KR25102 for InjectionDrug
Intravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts.
Placebo for KR25102 for InjectionDrug
Intravenous injection of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product (KR25102 for Injection) | Experimental | Single-ascending-dose (5 mg, 10 mg, 20 mg, 30 mg, 45 mg, 60 mg) and multiple-ascending-dose (10 mg, 20 mg, 30 mg) intravenous administration of KR25102 for Injection. Receives: Drug: KR25102 for Injection |
| Placebo | Placebo comparator | Matching placebo for KR25102 for Injection, administered intravenously. Receives: Drug: Placebo for KR25102 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs)
including vital signs, physical examination (neurological examination and injection-site examination included), 12-lead electrocardiogram, laboratory tests, abdominal ultrasonography, etc.
Measured: From study drug administration to 15 days after the last dose
Secondary outcomes (16)
Single-Dose Pharmacokinetic (PK) Parameters
AUC₀-ₜ
Measured: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
AUC₀-inf
Measured: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Tmax
Measured: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Tlag
Measured: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Cmax
Measured: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
t1/2
Measured: From study drug administration to 120 hours after single dose administration
Multiple-dose Pharmacokinetic (PK) Parameters
Cmin,ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Ctrough
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Cmax,ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Cav,ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
AUCtau，ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
CLss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Tmax,ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
t1/2,ss
Measured: From multiple-dose administration to 120 hours after the 7th dose
QTcF Interval Changes and Correlation With Plasma Drug Concentration
Changes in QTcF interval relative to baseline (ΔQTcF), changes relative to placebo (ΔΔQTcF)
Measured: From study drug administration to 24 hours after dosing
QTcF Interval Changes and Correlation With Plasma Drug Concentration
changes relative to placebo (ΔΔQTcF)
Measured: From study drug administration to 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, Principal investigator, The Third Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618156
- Sponsor's protocol ID
- KR25102-202601
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to commercial confidentiality and privacy protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Adult Chinese Participants
- ClinicalTrials.gov ID
- NCT07618156
- Acronym / sponsor ID
- KR25102-202601
- Conditions
- Healthy Volunteers (HV)
- Keywords
- KR25102, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Jun 2026 (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.
Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.
Detailed description
This study adopts a single-center, randomized, double-blind, placebo-controlled parallel-group, dose-escalation design.
This single ascending dose (SAD) study is designed with six dose cohorts: 5 mg, 10 mg, 20 mg, 30 mg, 45 mg, and 60 mg. A total of 53 healthy adult participants are planned to be enrolled.
Three participants are planned for the 5 mg cohort, randomized in a 2:1 ratio of investigational product to placebo. Each of the remaining five dose cohorts will enroll 10 participants, randomized in an 8:2 ratio of investigational product to placebo.
For the multiple ascending dose (MAD) part, three dose cohorts (10 mg, 20 mg, and 30 mg) are planned. A total of 30 healthy adult participants will be enrolled, with 10 participants per cohort randomized in an 8:2 ratio of investigational product to placebo.Subjects will receive once daily administration for 7 consecutive days according to the randomization scheme.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product (KR25102 for Injection) | Experimental | Drug: KR25102 for InjectionSingle-ascending-dose (5 mg, 10 mg, 20 mg, 30 mg, 45 mg, 60 mg) and multiple-ascending-dose (10 mg, 20 mg, 30 mg) intravenous administration of KR25102 for Injection. |
| Placebo | Placebo comparator | Drug: Placebo for KR25102 for InjectionMatching placebo for KR25102 for Injection, administered intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);
- Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m² (inclusive of boundary values);
- Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures;
- Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;
- For groups requiring pain testing: willing to undergo pain tests and pass training; with no wounds or skin diseases on the skin at the pain-stimulated site;
Key exclusion criteria (11 listed)
- Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator;
- Subjects with personal or family history of hereditary angioedema;
- Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;
- Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening.
- Subjects who have used any hepatic enzyme inhibitors/inducers within 1 month before dosing (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.).
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 |
|---|---|---|
| KR25102 for InjectionIntravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts. | Drug | Investigational Product (KR25102 for Injection) |
| Placebo for KR25102 for InjectionIntravenous injection of matching placebo. | Drug | Placebo |
Primary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: From study drug administration to 15 days after the last dose
including vital signs, physical examination (neurological examination and injection-site examination included), 12-lead electrocardiogram, laboratory tests, abdominal ultrasonography, etc.
16 secondary outcomes
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Time frame: From study drug administration to 120 hours after single dose administration
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Time frame: From multiple-dose administration to 120 hours after the 7th dose
QTcF Interval Changes and Correlation With Plasma Drug Concentration
Time frame: From study drug administration to 24 hours after dosing
QTcF Interval Changes and Correlation With Plasma Drug Concentration
Time frame: From study drug administration to 24 hours after dosing
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 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to commercial confidentiality and privacy protection requirements.
Related trials for Healthy Volunteers (HV)
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
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.
Guoping Yang principal investigator
The Third Xiangya Hospital, Central South University
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 KR25102 for Injection in people with Healthy Volunteers (HV), run by Jiangxi Kvvit Pharmaceutical 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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. Some participants in this study may receive a placebo. 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 Man Xu (+86-19979703650, xuman@kvvit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) (time frame: From study drug administration to 15 days after the last 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 1 Jun 2026.