Healthy VolunteersPhase 1NCT07343323
A First-in-Human Study of KINE-101 in Healthy Volunteers
A Phase 1 study testing KINE-101 in people with Healthy Volunteers, run by Kine Sciences Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study that evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) formulations of KINE-101 in healthy volunteers at a single study center. 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
- What is being tested?
- KINE-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 31 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed IRB-approved informed consent before any screening procedures.
- Healthy subjects with no clinically significant illness or disease based on medical history, physical exam, ECG, and lab tests.
- Males and females aged 18-55 years at screening.
- Nonsmokers or no nicotine use for ≥1 year; urine cotinine <200 ng/mL at screening and admission.
- BMI 18.5-30.0 kg/m² and body weight ≥50 kg at screening.
- Suitable veins for venipuncture/cannulation.
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- Able to fast overnight (≥10 hours).
- Male subjects agree to use condoms during intercourse and for 1 month after last IMP dose.
- Male subjects must not donate sperm from dosing day until 1 month after last IMP dose.
- Female subjects must be of non-childbearing potential (postmenopausal ≥12 months with FSH >40 IU/L or surgical sterilization such as hysterectomy, tubal ligation, bilateral oophorectomy/salpingectomy).
Who cannot join
- Received an investigational medicinal product (IMP) within 30 days or 5× half-life before first IMP administration.
- History of alcohol abuse within 2 years, weekly intake >21 units, or positive alcohol test at screening/admission.
- Current smokers or nicotine use within 12 months; positive urine cotinine at screening/admission.
- Clinically significant abnormal labs: ALT, AST, or total bilirubin >ULN (or >1.5×ULN if Gilbert's), serum creatinine >ULN, eGFR <80 mL/min/1.73 m², abnormal TSH, or other clinically relevant abnormal values.
- Positive drug abuse test at screening or admission.
- Positive HBsAg, anti-HCV, or HIV antibody at screening.
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- Clinically significant psychiatric, cardiovascular, renal, hepatic, or chronic respiratory disease, including arrhythmia.
- Supine BP <90 or >140 mmHg systolic, or <50 or >90 mmHg diastolic after 5 minutes supine.
- Supine pulse <50 bpm or >100 bpm after 5 minutes supine.
- Personal or family history of long QTc syndrome, sudden cardiac death, or hERG mutation.
- Severe adverse reaction or hypersensitivity to any drug or excipients.
- Blood donation or loss >400 mL within 3 months or hemoglobin below normal limits.
- Use of prohibited medications, OTC drugs, herbal remedies, or supplements within 28 days before IMP administration.
- Received live or attenuated vaccines or systemic corticosteroids within 3 months prior to first IMP dose.
- Conditions interfering with drug absorption, distribution, metabolism, or excretion.
- Employees of sponsor/CRO or close relatives involved in the study.
- Unable to communicate meaningfully with study staff.
- QTcF >450 ms at screening or admission.
- Significant liver impairment or abnormal conjugated/direct bilirubin >ULN.
- Consumption of methylxanthines (tea, coffee, chocolate), quinine-containing drinks, grapefruit, Seville oranges, poppy seeds, or alcohol within protocol-defined windows before IMP administration.
- Investigator judges subject unfit for any reason.
- Positive SARS-CoV-2 RT-PCR within 4 weeks prior to screening.
- COVID-19 symptoms within 14 days prior to screening.
- Severe COVID-19 history (e.g., ECMO, mechanical ventilation).
- Unable to attend in-person visits per site COVID guidelines.
- Scheduled to receive COVID-19 vaccination within 2 weeks before or after IMP administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Center, Double-blind, Placebo-controlled, First in Human Study With Single Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Subcutaneous Injections of KINE-101 in Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study that evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) formulations of KINE-101 in healthy volunteers at a single study center. Five cohorts of eight subjects each (six receiving KINE-101 and two receiving placebo) are admitted on Day -1, receive a single dose of investigational medicinal product (IMP) on Day 1, and remain in-house until Day 3, followed by outpatient visits on Days 7, 14, 28, and 42. Sentinel dosing applies in the first sub-cohort of each cohort: two sentinel subjects are dosed at least 10 minutes apart, and if no safety concerns arise during the 48-hour post-dose evaluation period, the remaining subjects in the cohort are subsequently dosed. Dosing in the second sub-cohort also occurs at intervals of at least 10 minutes. Four cohorts receive the IV formulation, with doses escalating from 10 mg up to an anticipated maximum of 300 mg. To compare relative bioavailability and characterize PK after subcutaneous administration, one SC cohort receives a single 96.8 mg dose. The number of cohorts and dose progression depend on emerging safety and PK data. Decisions to escalate, repeat, or modify dose levels are made by the Safety Review Committee (SRC), and additional cohorts may be added if deemed necessary.
- Conditions
- Healthy Volunteers
- Being tested
- KINE-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINE-101Drug
KINE-101 injection, 12.5 mg/mL, administered once either intravenously (10 mg, 30 mg, 100 mg, or 300 mg) or subcutaneously (96.8 mg) on Day 1, depending on cohort.
PlaceboDrug
Sterile 0.9% sodium chloride solution, administered once intravenously or subcutaneously on Day 1, matching the route of the investigational product.
| Study group | Role | What they receive |
|---|---|---|
| KINE-101 | Experimental | Not described Receives: Drug: KINE-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Incidence, severity, and relationship of treatment-emergent adverse events following single ascending doses of KINE-101.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Hematology
Count of participants with clinically significant abnormal hematology findings (e.g., white blood cell count, hemoglobin, platelet count), as defined per protocol.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Clinical Chemistry
Count of participants with clinically significant abnormal clinical chemistry findings (e.g., ALT, AST, creatinine), as defined per protocol.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Urinalysis
Count of participants with clinically significant abnormal urinalysis findings (e.g., bilirubin, glucose, pH and specific gravity), as defined per protocol.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Vital Signs
Count of participants with clinically significant abnormal vital sign findings (e.g., systolic and diastolic blood pressure, pulse, body temperature, respiratory rate), as defined per protocol.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Electrocardiogram
Count of participants with clinically significant abnormal 12-lead electrocardiogram findings (e.g., PR interval, QRS interval, QT interval), as defined per protocol.
Measured: Day 1 to Day 42
Number of Participants with Clinically Significant Abnormal Physical Examination
Count of participants with clinically significant abnormal physical examination findings, as defined per protocol.
Measured: Day 1 to Day 42
Local Tolerability and Injection/Infusion Site Reactions
Local tolerability and pain assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst possible pain). Higher scores indicate worse outcomes, as defined per protocol.
Measured: Day 1 to Day 42
Secondary outcomes (5)
Peak Plasma Concentration of KINE-101 (Cmax)
Maximum observed plasma concentration of KINE-101.
Measured: From predose on Day 1 through 24 hours postdose (Day 2)
Time to Peak Plasma Concentration of KINE-101 (Tmax)
Time to reach the maximum observed plasma concentration of KINE-101.
Measured: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve of KINE-101 from predose to the time of the last quantifiable concentration.
Measured: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau)
Area under the plasma concentration-time curve of KINE-101 from predose over the dosing interval following single ascending doses.
Measured: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf)
Area under the plasma concentration-time curve of KINE-101 from predose extrapolated to infinite time.
Measured: From predose on Day 1 through 24 hours postdose (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start5 Nov 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kine Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanna Park, Study director, Kine Sciences Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343323
- Sponsor's protocol ID
- RA101-CR3-001
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Double-blind, Placebo-controlled, First in Human Study With Single Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Subcutaneous Injections of KINE-101 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07343323
- Acronym / sponsor ID
- RA101-CR3-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kine Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 15 Jan 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.
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study that evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) formulations of KINE-101 in healthy volunteers at a single study center. Five cohorts of eight subjects each (six receiving KINE-101 and two receiving placebo) are admitted on Day -1, receive a single dose of investigational medicinal product (IMP) on Day 1, and remain in-house until Day 3, followed by outpatient visits on Days 7, 14, 28, and 42. Sentinel dosing applies in the first sub-cohort of each cohort: two sentinel subjects are dosed at least 10 minutes apart, and if no safety concerns arise during the 48-hour post-dose evaluation period, the remaining subjects in the cohort are subsequently dosed. Dosing in the second sub-cohort also occurs at intervals of at least 10 minutes. Four cohorts receive the IV formulation, with doses escalating from 10 mg up to an anticipated maximum of 300 mg. To compare relative bioavailability and characterize PK after subcutaneous administration, one SC cohort receives a single 96.8 mg dose. The number of cohorts and dose progression depend on emerging safety and PK data. Decisions to escalate, repeat, or modify dose levels are made by the Safety Review Committee (SRC), and additional cohorts may be added if deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KINE-101 | Experimental | Drug: KINE-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed IRB-approved informed consent before any screening procedures.
- Healthy subjects with no clinically significant illness or disease based on medical history, physical exam, ECG, and lab tests.
- Males and females aged 18-55 years at screening.
- Nonsmokers or no nicotine use for ≥1 year; urine cotinine <200 ng/mL at screening and admission.
- BMI 18.5-30.0 kg/m² and body weight ≥50 kg at screening.
Key exclusion criteria (26 listed)
- Received an investigational medicinal product (IMP) within 30 days or 5× half-life before first IMP administration.
- History of alcohol abuse within 2 years, weekly intake >21 units, or positive alcohol test at screening/admission.
- Current smokers or nicotine use within 12 months; positive urine cotinine at screening/admission.
- Clinically significant abnormal labs: ALT, AST, or total bilirubin >ULN (or >1.5×ULN if Gilbert's), serum creatinine >ULN, eGFR <80 mL/min/1.73 m², abnormal TSH, or other clinically relevant abnormal values.
- Positive drug abuse test at screening or admission.
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 |
|---|---|---|
| KINE-101KINE-101 injection, 12.5 mg/mL, administered once either intravenously (10 mg, 30 mg, 100 mg, or 300 mg) or subcutaneously (96.8 mg) on Day 1, depending on cohort. | Drug | KINE-101 |
| PlaceboSterile 0.9% sodium chloride solution, administered once intravenously or subcutaneously on Day 1, matching the route of the investigational product. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Day 1 to Day 42
Incidence, severity, and relationship of treatment-emergent adverse events following single ascending doses of KINE-101.
Number of Participants with Clinically Significant Abnormal Hematology
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal hematology findings (e.g., white blood cell count, hemoglobin, platelet count), as defined per protocol.
Number of Participants with Clinically Significant Abnormal Clinical Chemistry
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal clinical chemistry findings (e.g., ALT, AST, creatinine), as defined per protocol.
Number of Participants with Clinically Significant Abnormal Urinalysis
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal urinalysis findings (e.g., bilirubin, glucose, pH and specific gravity), as defined per protocol.
Number of Participants with Clinically Significant Abnormal Vital Signs
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal vital sign findings (e.g., systolic and diastolic blood pressure, pulse, body temperature, respiratory rate), as defined per protocol.
Number of Participants with Clinically Significant Abnormal Electrocardiogram
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal 12-lead electrocardiogram findings (e.g., PR interval, QRS interval, QT interval), as defined per protocol.
Number of Participants with Clinically Significant Abnormal Physical Examination
Time frame: Day 1 to Day 42
Count of participants with clinically significant abnormal physical examination findings, as defined per protocol.
Local Tolerability and Injection/Infusion Site Reactions
Time frame: Day 1 to Day 42
Local tolerability and pain assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst possible pain). Higher scores indicate worse outcomes, as defined per protocol.
5 secondary outcomes
Peak Plasma Concentration of KINE-101 (Cmax)
Time frame: From predose on Day 1 through 24 hours postdose (Day 2)
Time to Peak Plasma Concentration of KINE-101 (Tmax)
Time frame: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
Time frame: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau)
Time frame: From predose on Day 1 through 24 hours postdose (Day 2)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf)
Time frame: From predose on Day 1 through 24 hours postdose (Day 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
Hanna Park study director
Kine Sciences Co., Ltd.
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 KINE-101 in people with Healthy Volunteers, run by Kine Sciences Co., Ltd. at 1 site in United States.
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 10 inclusion and 26 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: finished, as of the sponsor's last update on 15 Jan 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Day 1 to Day 42). The study lists 8 primary outcomes in all. 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 15 Jan 2026.