Trials / Completed
CompletedNCT03577509
Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABCD | Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion. |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2018-09-14
- Completion
- 2018-09-14
- First posted
- 2018-07-05
- Last updated
- 2018-10-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03577509. Inclusion in this directory is not an endorsement.