Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers (HV)
• Intervention / Treatment: Drug: KR25102 for Injection; Drug: Placebo for KR25102 for Injection

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 Type: Interventional
• Enrollment (Estimated): 83
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Man Xu; Phone Number: +86-19979703650; Email: xuman@kvvit.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410006
      • The Third Xiangya Hospital, Central South University
      • Contact: Guoping Yang; Phone Number: 0731-88618938; Email: ygp9880@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);
2. 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);
3. 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;
4. Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;
5. 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;
6. 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.

Exclusion Criteria:

1. 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;
2. Subjects with personal or family history of hereditary angioedema;
3. Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;
4. 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.
5. 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.).
6. 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.
7. Subjects with a history of drug abuse or positive results in drug abuse screening;
8. Subjects with clinically significant abnormal physical examination results at screening or baseline as judged by the investigator;
9. Subjects with positive screening results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody;
10. 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;
11. Subjects who fail pain test training as judged by the investigator (only applicable to groups requiring pain testing).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product (KR25102 for Injection); 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.	Drug: KR25102 for Injection; Intravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts.
Placebo Comparator: Placebo; Matching placebo for KR25102 for Injection, administered intravenously.	Drug: Placebo for KR25102 for Injection; Intravenous injection of matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From study drug administration to 15 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-Dose Pharmacokinetic (PK) Parameters	AUC₀-ₜ	From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters	AUC₀-inf	From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters	Tmax	From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters	Tlag	From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters	Cmax	From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters	t1/2	From study drug administration to 120 hours after single dose administration
Multiple-dose Pharmacokinetic (PK) Parameters	Cmin,ss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	Ctrough	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	Cmax,ss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	Cav,ss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	AUCtau，ss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	CLss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	Tmax,ss	From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters	t1/2,ss	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)	From study drug administration to 24 hours after dosing
QTcF Interval Changes and Correlation With Plasma Drug Concentration	changes relative to placebo (ΔΔQTcF)	From study drug administration to 24 hours after dosing

Collaborators and Investigators

• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Guoping Yang, The Third Xiangya Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: KR25102, Pharmacokinetics, Safety
• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: KR25102-202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to commercial confidentiality and privacy protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No