HealthyPhase 1NCT02219971
Phase I Study of Kukoamine B Mesilate in Healthy Volunteers
A Phase 1 study testing Kukoamine B Mesilate in people with Healthy, run by Tianjin Chasesun Pharmaceutical Co., LTD at 1 site in China.
Trial summary
The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Kukoamine B Mesilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to 6 May 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: male or female, each sex ratio does not exceed 2/3;
- 18-45 years (including upper and lower limit), the general situation is good;
- Body mass index (BMI) in 19-28 (including upper and lower limit of the range), BW ≥ 50kg (female) and 60kg (male);
- Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
- Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.
Who cannot join
- Primary disease in important organs;
- Mental or physical disability;
- Familial hereditary disease;
- Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90~140mmHg, beyond the scope of 50~90mmHg, Or pulse (HR) beyond 50bpm~100bpm
- Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
- History of immunodeficiency diseases, including HIV antibody positive;
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- Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
- Alcohol and drug abusers;
- Smoking and drinking are (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;
- Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
- Before entering the group 4 weeks using any prescription drugs before entering the group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics, food additives), or into the group within 2 weeks before taking effect of drug metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in CRF;
- The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
- There are drugs, the clinical significance of the history of food allergy and atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs or similar drug allergy test;
- Lactating women, pregnant women or unable to take effective contraceptive measures;
- Researchers believe that the other is not suitable to take the test factors participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance and Pharmacokinetics of a Single Intravenous Injection Kukoamine B Mesilate in Healthy Volunteers
The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer
- Conditions
- Healthy
- Being tested
- Kukoamine B Mesilate
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kukoamine B MesilateDrug
Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Kukoamine B Mesilate 0.005mg/kg | Experimental | Pre-test,open study: Kukoamine B Mesilate 0.005mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.02mg/kg + Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.02mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.04mg/kg +Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.04mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.08mg/kg + Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.08mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.12mg/kg + Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.12mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.24mg/kg + Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.24mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
| Kukoamine B Mesilate 0.48mg/kg + Placebo | Experimental | Dose Escalation: Kukoamine B Mesilate 0.48mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. Receives: Drug: Kukoamine B Mesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events.
AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.
Measured: 7 days
Secondary outcomes (1)
Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)
Blood:（Pre Test）0,20min,40min after initiation of drug administration and 0,10min,20min,30min,45min,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h,24h after the end of administration;(Formal Test) 0,20min,40min after initiation of drug administration and 0,30min,1h,2h,3h,4h,6h,8h,12h,16h,24h after the end of administration; Urine:(Pre Test) 0,0-4h,4-8h,8-12h,12-24h,24-48h after initiation of drug administration;(Formal Test) 0,0-5h,5-9h,9-13h,13-25h,25-49h after initiation of drug administration .
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion6 May 2015
- Study completion6 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Chasesun Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China
- Responsible party
- Sponsor
- Investigators
- SHUAI CHEN, Study director, TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219971
- Sponsor's protocol ID
- HR-KB101
- Other IDs
- ChiCTR-TRC-14005111
- Status last verified
- May 2016
- First submitted
- 16 Aug 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu H, Zhao Q, Yuan Y, Wang Z, Wang T, Tian W, Zhong W, Jiang J, Chen S, Kong K, Jin C, Hu P. First-in-Human Safety, Tolerability, and Pharmacokinetics of Single-Dose Kukoamine B Mesylate in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase I Study. Infect Dis Ther. 2024 Feb;13(2):361-371. doi: 10.1007/s40121-024-00921-6. Epub 2024 Jan 30.
PubMed 38291280
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance and Pharmacokinetics of a Single Intravenous Injection Kukoamine B Mesilate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02219971
- Acronym / sponsor ID
- HR-KB101
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tianjin Chasesun Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China
- Study start
- Aug 2014 (actual)
- Primary completion
- 6 May 2015 (actual)
- Study completion
- 6 May 2015 (actual)
- First posted
- 19 Aug 2014 (estimated)
- 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.
The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Kukoamine B Mesilate 0.005mg/kg | Experimental | Drug: Kukoamine B MesilatePre-test,open study: Kukoamine B Mesilate 0.005mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.02mg/kg + Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.02mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.04mg/kg +Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.04mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.08mg/kg + Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.08mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.12mg/kg + Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.12mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.24mg/kg + Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.24mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
| Kukoamine B Mesilate 0.48mg/kg + Placebo | Experimental | Drug: Kukoamine B MesilateDose Escalation: Kukoamine B Mesilate 0.48mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gender: male or female, each sex ratio does not exceed 2/3;
- 18-45 years (including upper and lower limit), the general situation is good;
- Body mass index (BMI) in 19-28 (including upper and lower limit of the range), BW ≥ 50kg (female) and 60kg (male);
- Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
- Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.
Key exclusion criteria (15 listed)
- Primary disease in important organs;
- Mental or physical disability;
- Familial hereditary disease;
- Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90~140mmHg, beyond the scope of 50~90mmHg, Or pulse (HR) beyond 50bpm~100bpm
- Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
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 |
|---|---|---|
| Kukoamine B MesilateKukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers. | Drug | Kukoamine B Mesilate 0.005mg/kg, Kukoamine B Mesilate 0.02mg/kg + Placebo, Kukoamine B Mesilate 0.04mg/kg +Placebo, Kukoamine B Mesilate 0.08mg/kg + Placebo, Kukoamine B Mesilate 0.12mg/kg + Placebo, Kukoamine B Mesilate 0.24mg/kg + Placebo, Kukoamine B Mesilate 0.48mg/kg + Placebo |
Primary outcome
Incidence of adverse events.
Time frame: 7 days
AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.
1 secondary outcome
Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)
Time frame: 48h
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 3 May 2017.
- Derived from this study: PubMed 38291280Liu H, Zhao Q, Yuan Y, Wang Z, Wang T, Tian W, Zhong W, Jiang J, Chen S, Kong K, Jin C, Hu P. First-in-Human Safety, Tolerability, and Pharmacokinetics of Single-Dose Kukoamine B Mesylate in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase I Study. Infect Dis Ther. 2024 Feb;13(2):361-371. doi: 10.1007/s40121-024-00921-6. Epub 2024 Jan 30.
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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.
SHUAI CHEN study director
TIAN JIN CHASE SUN PHARMACEUTICAL 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 Kukoamine B Mesilate in people with Healthy, run by Tianjin Chasesun 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 5 inclusion and 15 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 3 May 2017. 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. 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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219971, which also lists 1 linked publication.
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 3 May 2017.