Healthy VolunteersPhase 1NCT07324642
A Phase 1 MAD 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 South Korea.
Trial summary
This is a randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 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
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2025to 25 Aug 2025
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adults aged 19 to 55 years
- Body weight ≥ 50.0 kg and Body Mass Index (BMI) between 18.5 and 30.0 kg/m²
- Clinically healthy with no congenital or chronic diseases requiring treatment
- Normal findings in physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at screening
- Provided written informed consent and willing to comply with all study restrictions and procedures
Who cannot join
- History or presence of clinically significant hepatic, renal, cardiovascular, respiratory, neurological, hematologic, endocrine, psychiatric, or malignant diseases
- Abnormal ECG findings (QTc > 450 ms for males or > 470 ms for females; PR > 200 ms; QRS > 120 ms)
- Abnormal liver or renal function (AST, ALT, ALP, γ-GT, or total bilirubin > 2× ULN; eGFR < 60 mL/min/1.73 m²)
- Positive drug abuse test or history of substance abuse
- Abnormal vital signs at screening (SBP ≤ 90 or ≥ 150 mmHg; DBP ≤ 60 or ≥ 100 mmHg; pulse ≤ 40 or ≥ 100 bpm)
- Vaccination with live or attenuated vaccines or systemic corticosteroid use within 3 months before dosing
Show all 16Show fewer
- Use of enzyme-inducing/inhibiting drugs, herbal medicines, or other investigational products within 1-3 months before dosing
- Donation or transfusion of blood within 3 months before dosing
- Regular alcohol consumption > 21 units/week, or inability to abstain during the study
- Current smokers (> 10 cigarettes/day) or inability to refrain from smoking during study participation
- Intake of alcohol, grapefruit, quinine, Seville orange, or caffeine-containing products within 24-72 hours before dosing and during sampling periods
- Engagement in strenuous exercise within 48 hours before dosing
- Pregnant or breastfeeding women, or men and women not using reliable contraception
- Recent COVID-19 or influenza infection or vaccination within 2 weeks before dosing
- Difficult venous access or positive alcohol breath test
- Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
About this study
Official title: A Randomized, Single-center, Single-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Characteristics of Multiple Intravenous Infusions of KINE-101 in Healthy Adult Volunteers
This is a randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers.
The study includes three sequential cohorts with a total of 24 subjects (8 subjects per cohort; 6 assigned to KINE-101 and 2 to placebo). Subjects in the treatment groups receive KINE-101 once daily for 7 consecutive days at doses corresponding to their assigned cohort (Cohort 1: 120 mg, Cohort 2: 240 mg, Cohort 3: 360 mg). Subjects in the placebo group receive 0.9% saline under identical conditions. All subjects are admitted on Day -1, receive daily dosing from Day 1 through Day 7, and are discharged on Day 9 after completion of safety monitoring. Follow-up visits are conducted on Days 14, 21, 28, and 35. Dose escalation proceeds sequentially from the lowest-dose cohort (Cohort 1) to the highest-dose cohort (Cohort 3). Safety and tolerability data collected through Day 35 in each preceding cohort are reviewed before initiating dosing in the next higher-dose cohort.
- 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, intravenous infusion once daily for 7 days under fasting conditions.
PlaceboDrug
0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions.
| 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 Treatment-Emergent Adverse Events
Number and percentage of subjects experiencing any treatment-emergent adverse event (TEAE) following multiple intravenous administrations of KINE-101 or placebo. Safety assessments will also include concomitant medications, physical examinations, local injection site reactions, and vital signs.
Measured: From Day 1 to Day 35 (End of Study visit)
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) of KINE-101 following single and multiple doses.
Measured: From Day 1 (pre-dose) through Day 7 post-dose
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC) of KINE-101 following single and multiple doses.
Measured: From Day 1 (pre-dose) through Day 7 post-dose
Terminal half life (t½)
Terminal half life (t½) of KINE-101 following single and multiple doses.
Measured: From Day 1 (pre-dose) through Day 7 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start26 May 2025
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kine Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chungbuk National University Hospital
- Responsible party
- Sponsor
- Investigators
- Hanna Park, Study director, Kine Sciences Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324642
- Sponsor's protocol ID
- CIDP101-CR1-002P
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Single-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Characteristics of Multiple Intravenous Infusions of KINE-101 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07324642
- Acronym / sponsor ID
- CIDP101-CR1-002P
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kine Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chungbuk National University Hospital
- Study start
- 26 May 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 7 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 randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers.
The study includes three sequential cohorts with a total of 24 subjects (8 subjects per cohort; 6 assigned to KINE-101 and 2 to placebo). Subjects in the treatment groups receive KINE-101 once daily for 7 consecutive days at doses corresponding to their assigned cohort (Cohort 1: 120 mg, Cohort 2: 240 mg, Cohort 3: 360 mg). Subjects in the placebo group receive 0.9% saline under identical conditions. All subjects are admitted on Day -1, receive daily dosing from Day 1 through Day 7, and are discharged on Day 9 after completion of safety monitoring. Follow-up visits are conducted on Days 14, 21, 28, and 35. Dose escalation proceeds sequentially from the lowest-dose cohort (Cohort 1) to the highest-dose cohort (Cohort 3). Safety and tolerability data collected through Day 35 in each preceding cohort are reviewed before initiating dosing in the next higher-dose cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KINE-101 | Experimental | Drug: KINE-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female adults aged 19 to 55 years
- Body weight ≥ 50.0 kg and Body Mass Index (BMI) between 18.5 and 30.0 kg/m²
- Clinically healthy with no congenital or chronic diseases requiring treatment
- Normal findings in physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at screening
- Provided written informed consent and willing to comply with all study restrictions and procedures
Key exclusion criteria (16 listed)
- History or presence of clinically significant hepatic, renal, cardiovascular, respiratory, neurological, hematologic, endocrine, psychiatric, or malignant diseases
- Abnormal ECG findings (QTc > 450 ms for males or > 470 ms for females; PR > 200 ms; QRS > 120 ms)
- Abnormal liver or renal function (AST, ALT, ALP, γ-GT, or total bilirubin > 2× ULN; eGFR < 60 mL/min/1.73 m²)
- Positive drug abuse test or history of substance abuse
- Abnormal vital signs at screening (SBP ≤ 90 or ≥ 150 mmHg; DBP ≤ 60 or ≥ 100 mmHg; pulse ≤ 40 or ≥ 100 bpm)
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, intravenous infusion once daily for 7 days under fasting conditions. | Drug | KINE-101 |
| Placebo0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions. | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From Day 1 to Day 35 (End of Study visit)
Number and percentage of subjects experiencing any treatment-emergent adverse event (TEAE) following multiple intravenous administrations of KINE-101 or placebo. Safety assessments will also include concomitant medications, physical examinations, local injection site reactions, and vital signs.
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: From Day 1 (pre-dose) through Day 7 post-dose
Area under the plasma concentration-time curve (AUC)
Time frame: From Day 1 (pre-dose) through Day 7 post-dose
Terminal half life (t½)
Time frame: From Day 1 (pre-dose) through Day 7 post-dose
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 7 Jan 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
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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. 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 South Korea.
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 16 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 7 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 South Korea. 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 Treatment-Emergent Adverse Events (time frame: From Day 1 to Day 35 (End of Study visit)). 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 7 Jan 2026.