Trials / Completed
CompletedNCT03857568
A Trial of SHR0410 Injection in Hemodialysis Participants.
A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Atridia Pty Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis.
Detailed description
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session. Safety assessments, PK assessments and efficacy evaluations will be performed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR0410 | drug will be dosed repeatedly |
| DRUG | Placebo | Placebo will be dosed repeatedly |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2019-11-08
- Completion
- 2019-11-08
- First posted
- 2019-02-28
- Last updated
- 2020-07-10
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03857568. Inclusion in this directory is not an endorsement.