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Monoclonal Antibodies

XmAb27564 for Safety

Phase 1
Waitlist Available
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights

Study Summary

This trial is testing a new drug, XmAb27564, to see if it is safe and works in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0
Secondary outcome measures
PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood
PD: Measurement of Change in Number of Regulatory T Cells
PD: Measurement of Change in Number of Subsets of Conventional T Cells in Blood
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or FExperimental Treatment1 Intervention
Group II: Single Ascending Dose - Placebo Subcutaneous injection of placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XmAb27564
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,705 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
15,324 Total Patients Enrolled
David Liebowitz, MDStudy DirectorVice President, Clinical Development, Xencor
2 Previous Clinical Trials
570 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort currently assessing this medical trial?

"Affirmative. The details on clinicaltrials.gov indicate that this experimental therapy is actively recruiting participants, having been listed since April 19th 2021 and last updated July 19th 2022. A total of 48 patients are required at a single site for the trial to be complete."

Answered by AI

Does this trial still have availability for participants?

"According to the clinicaltrials.gov page, recruitment for this research endeavour is ongoing since its initial posting on April 19th 2021 and last update on July 19th 2022."

Answered by AI

Has the Food and Drug Administration sanctioned XmAb27564 for therapeutic use?

"As this is a Phase 1 trial, which typically indicates limited data regarding efficacy and safety, XmAb27564 was rated a score of 1."

Answered by AI

Is this trial open to adults over 25 years old?

"This medical trial only allows individuals aged 21-55 to participate, in accordance with the established inclusion criteria."

Answered by AI

What are the criteria for enrollment in this clinical experiment?

"To qualify for the clinical trial, volunteers must be between 21 and 55 years old and have proven to not pose a safety risk. For this study, 48 participants are needed in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
ICON Early Phase Services, LLC

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. ICON Early Phase Services, LLC: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
2021. "Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04857866.
~12 spots leftby Apr 2025
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