Trials / Withdrawn
WithdrawnNCT04460105
Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia
A Phase 1b, Randomized, Double-blind, Single and Repeat Dosing Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab When Added to Standard-of-Care in Subjects Hospitalized With COVID-19 Pneumonia
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, pharmacokinetic and pharmacodynamics of lanadelumab administered by intravenous (IV) infusion when added to standard-of-care (SoC) in adults hospitalized with COVID-19 pneumonia.
Detailed description
This study consists of two cohorts (Cohort 1 \[Single-dose Cohort\], and Cohort 2 \[Repeat-dose Cohort\]). Up to approximately 24 participants will be enrolled in this study, in which up to 12 participants may be enrolled into Cohort 1. However, Cohort 1 will be closed upon implementation of Amendment 2. Approximately 12 participants will be enrolled in Cohort 2. Participants will be randomized in 3:1 ratio (9 lanadelumab: 3 placebo) in each Cohort.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lanadelumab | Participants will receive 300 mg of lanadelumab IV infusion on Day 1 and Day 4. |
| OTHER | Placebo | Participants will receive placebo matching IV infusion on Day 1 and Day 4. |
Timeline
- Start date
- 2020-10-31
- Primary completion
- 2021-01-27
- Completion
- 2021-01-27
- First posted
- 2020-07-07
- Last updated
- 2020-10-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04460105. Inclusion in this directory is not an endorsement.