Trials / Completed
CompletedNCT05058118
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FL058 | 50mg、250mg、500mg、1000mg、1500mg、2000mg |
| DRUG | Placebo | empty bottle |
Timeline
- Start date
- 2019-12-08
- Primary completion
- 2020-06-03
- Completion
- 2020-06-03
- First posted
- 2021-09-27
- Last updated
- 2021-09-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05058118. Inclusion in this directory is not an endorsement.