Invasive Fungal DiseasePhase 1NCT03577509
Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
A Phase 1 study testing ABCD in people with Invasive Fungal Disease, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Fungal Disease
- What is being tested?
- ABCD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2018to 14 Sep 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/[height(m)]2.
- Subjects are fully informed and voluntarily consent to participate in this study.
Who cannot join
- History of allergy or hypersensitivity.
- Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc.
- A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- Lost blood or donated more than 400 mL of blood within 3 months prior to the screening.
- Participation in a clinical drug study 30 days prior to present study.
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- Use of any other drugs within 2 weeks prior to the screening.
- Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
- The partner of the subject is unwilling to take effective contraceptive measures.
- Other unfavorable factors diagnosed by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
Read the detailed description
Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.
Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.
Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.
- Conditions
- Invasive Fungal Disease
- Being tested
- ABCD
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCDDrug
Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.
| Study group | Role | What they receive |
|---|---|---|
| ABCD | Experimental | Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg Receives: Drug: ABCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of single infusion of ABCD
Peak Plasma Concentration,.
Measured: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
Pharmacokinetics of single infusion of ABCD
Area under the plasma concentration versus time curve
Measured: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start2 Jul 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
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 Invasive Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Ph.D, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577509
- Sponsor's protocol ID
- LXMSB201701/PRO
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang ZW, Yu JC, Wang JJ, Chen YC, Wu JF, Chen YJ, Cao GY, Yang HJ, He JJ, Dai JY, Zhang JY, Zhang W, Yuan J, Li CL, Xu FY, Wang K, Wu XJ, Zhang J. Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans. Clin Ther. 2021 Nov;43(11):1921-1933.e7. doi: 10.1016/j.clinthera.2021.09.012. Epub 2021 Oct 20.
PubMed 34686365
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
- ClinicalTrials.gov ID
- NCT03577509
- Acronym / sponsor ID
- LXMSB201701/PRO
- Conditions
- Invasive Fungal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 5 Jul 2018 (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.
The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
Detailed description
Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.
Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.
Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABCD | Experimental | Drug: ABCDGroup1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/[height(m)]2.
- Subjects are fully informed and voluntarily consent to participate in this study.
Key exclusion criteria (10 listed)
- History of allergy or hypersensitivity.
- Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc.
- A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- Lost blood or donated more than 400 mL of blood within 3 months prior to the screening.
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 |
|---|---|---|
| ABCDIntravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion. | Drug | ABCD |
Primary outcome
Pharmacokinetics of single infusion of ABCD
Time frame: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
Peak Plasma Concentration,.
Pharmacokinetics of single infusion of ABCD
Time frame: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
Area under the plasma concentration versus time curve
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 9 Oct 2018.
- Derived from this study: PubMed 34686365Huang ZW, Yu JC, Wang JJ, Chen YC, Wu JF, Chen YJ, Cao GY, Yang HJ, He JJ, Dai JY, Zhang JY, Zhang W, Yuan J, Li CL, Xu FY, Wang K, Wu XJ, Zhang J. Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans. Clin Ther. 2021 Nov;43(11):1921-1933.e7. doi: 10.1016/j.clinthera.2021.09.012. Epub 2021 Oct 20.
- 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.
Jing Zhang, Ph.D principal investigator
Huashan Hospital
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 ABCD in people with Invasive Fungal Disease, run by CSPC ZhongQi Pharmaceutical Technology 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 2 inclusion and 10 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 9 Oct 2018. 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?
Pharmacokinetics of single infusion of ABCD (time frame: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion). The study lists 2 primary outcomes in all. 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 NCT03577509, 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 9 Oct 2018.