Trials / Withdrawn
WithdrawnNCT03751969
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous \[14C\]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK3486 | The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing \[14C\] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects. |
Timeline
- Start date
- 2020-03-30
- Primary completion
- 2020-11-01
- Completion
- 2020-12-01
- First posted
- 2018-11-23
- Last updated
- 2022-06-02
Source: ClinicalTrials.gov record NCT03751969. Inclusion in this directory is not an endorsement.