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Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers

NCT04857866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Safety in Healthy Volunteers

Interventions

DRUG

XmAb27564

Single ascending dose of XmAb27564

DRUG

Placebo

Single dose of placebo

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Xencor, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph Zitnik, MD · Executive Medical Director, Clinical Development, Xencor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857866 on ClinicalTrials.gov