HealthyPhase 1NCT04629287
Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection
A Phase 1 study testing KPCXM18 in people with Healthy, run by Kunming Pharmaceuticals, Inc..
Trial summary
to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KPCXM18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Feb 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ；
- General physical examination and physical and chemical examination are qualified.
- Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；
Who cannot join
- Any condition that might interfere with the procedures or tests in this study;
- Drinking（more than 14 units of alcohol per week） in 6 months ;
- Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ;
- Have special requirements on diet, or cannot follow a unified diet ;
- Used a clinical trial drug within 3 months prior to administration ;
- Positive blood pregnancy test of female subjects ;
- Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects
to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects
Read the detailed description
To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.
- Conditions
- Healthy
- Being tested
- KPCXM18, Placebo
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPCXM18Drug
KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route
PlaceboDrug
Placebo,blind,freeze-dried powder,ascending doses，Intravenous route
| Study group | Role | What they receive |
|---|---|---|
| KPCXM18 for injection | Experimental | KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route Receives: Drug: KPCXM18; Drug: Placebo |
| Placebo | Placebo comparator | Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route Receives: Drug: KPCXM18; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal vital signs
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Measured: through study completion, an average of 2 week
Number of subjects with abnormal laboratory
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Measured: through study completion, an average of 2 week
Number of subjects with abnormal physical examination
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination
Measured: through study completion, an average of 2 week
Number of subjects with abnormal electrocardiogram
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram
Measured: through study completion, an average of 2 week
Number of subjects with adverse events
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events
Measured: through study completion, an average of 2 week
Secondary outcomes (7)
Pharmacokinetics of KPCXM18 in plasma: Cmax
To characterize the pharmacokinetic parameters：Cmax of KPCXM18 after the first day administer
Measured: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: Tmax
To characterize the pharmacokinetic parameters：Tmax of KPCXM18 after the first day administer
Measured: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: AUC0-∞
To characterize the pharmacokinetic parameters： AUC0-∞ of KPCXM18 after the first day administer
Measured: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma:t1/2
To characterize the pharmacokinetic parameters： t1/2 of KPCXM18 after the
Measured: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: Cmax,ss
To characterize the pharmacokinetic parameters：Cmax,ss of KPCXM18 after the 14th day administer
Measured: Time Frame: Between Day 1 to 14 days
Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss
To characterize the pharmacokinetic parameters：AUC0-∞,ss of KPCXM18 after the 14th day administer
Measured: Time Frame: Between Day 1 to 14 days
Pharmacokinetics of KPCXM18 in plasma: Tmax,ss
To characterize the pharmacokinetic parameters：Tmax,ss of KPCXM18 after the 14th day administer
Measured: Time Frame: Between Day 1 to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Model description
- Randomized, blind, dose-incrementing, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yuhong huang, Prof., Principal investigator, Second Affiliated Hospital of Tianjin University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629287
- Sponsor's protocol ID
- KPCXM18/C101
- Other IDs
- CTR20202022
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 19 Nov 2020
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04629287
- Acronym / sponsor ID
- KPCXM18/C101
- Conditions
- Healthy
- Keywords
- stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 16 Nov 2020 (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.
to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects
Detailed description
To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, blind, dose-incrementing, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| KPCXM18 for injection | Experimental | Drug: KPCXM18, Drug: PlaceboKPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route |
| Placebo | Placebo comparator | Drug: KPCXM18, Drug: PlaceboPlacebo, freeze-dried powder,single and multiple ascending doses, Intravenous route |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ；
- General physical examination and physical and chemical examination are qualified.
- Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；
Key exclusion criteria (7 listed)
- Any condition that might interfere with the procedures or tests in this study;
- Drinking（more than 14 units of alcohol per week） in 6 months ;
- Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ;
- Have special requirements on diet, or cannot follow a unified diet ;
- Used a clinical trial drug within 3 months prior to administration ;
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 |
|---|---|---|
| KPCXM18KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route | Drug | KPCXM18 for injection, Placebo |
| PlaceboPlacebo,blind,freeze-dried powder,ascending doses，Intravenous route | Drug | KPCXM18 for injection, Placebo |
Primary outcome
Number of subjects with abnormal vital signs
Time frame: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Number of subjects with abnormal laboratory
Time frame: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Number of subjects with abnormal physical examination
Time frame: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination
Number of subjects with abnormal electrocardiogram
Time frame: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram
Number of subjects with adverse events
Time frame: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events
7 secondary outcomes
Pharmacokinetics of KPCXM18 in plasma: Cmax
Time frame: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: Tmax
Time frame: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: AUC0-∞
Time frame: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma:t1/2
Time frame: Time Frame: Between Day 1 to 7 days
Pharmacokinetics of KPCXM18 in plasma: Cmax,ss
Time frame: Time Frame: Between Day 1 to 14 days
Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss
Time frame: Time Frame: Between Day 1 to 14 days
Pharmacokinetics of KPCXM18 in plasma: Tmax,ss
Time frame: Time Frame: Between Day 1 to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- 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. This study is not recruiting at the moment.
yuhong huang, Prof. principal investigator
Second Affiliated Hospital of Tianjin University of TCM
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KPCXM18 in people with Healthy, run by Kunming Pharmaceuticals, Inc..
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact duo gao, ph.D (0871-68319868 ext. 3502, duo.gao@kpc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with abnormal vital signs (time frame: through study completion, an average of 2 week). The study lists 5 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 19 Nov 2020.