Trials / Completed
CompletedNCT04857866
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®27564 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Xencor, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending-dose study of subcutaneously administered XmAb27564 or placebo in healthy male and female subjects.
Detailed description
This study will determine the safety and tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of XmAb27564 in normal healthy volunteers. XmAb27564 is an engineered IL-2 mutein being developed for autoimmune diseases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XmAb27564 | Single ascending dose of XmAb27564 |
| DRUG | Placebo | Single dose of placebo |
Timeline
- Start date
- 2021-04-19
- Primary completion
- 2022-11-10
- Completion
- 2022-11-10
- First posted
- 2021-04-23
- Last updated
- 2023-03-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04857866. Inclusion in this directory is not an endorsement.