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CompletedNCT04857866Updated Mar 1, 2023

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

A Phase 1 interventional study of XmAb27564 and Placebo in Safety in Healthy Volunteers, sponsored by Xencor, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Xencor, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2022, 3 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Safety in Healthy Volunteers

Keywords

  • Healthy Volunteers
03

In context

Lead sponsor

Xencor, Inc. is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 2 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Total body weight 50.0 to 100.0 kg and body mass index (BMI) 19.0 to 35.0 kg/m2
  • In good general health with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease.
  • A nonsmoker for at least 12 weeks preceding screening
  • Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 45 days after administration of investigational product (IP).
  • Fertile male and female subjects must be willing to practice a highly effective method of birth control during and for 45 days after administration of IP and agree not to donate sperm from screening through 45 days after administration of IP.

Exclusion criteria

Exclusion Criteria:

  • Subjects who have a clinically relevant history or presence of diseases or disorders that would pose a significant risk to subject's safety or significantly interfere with the study evaluation, procedures, or completion
  • Subjects with history of any cardiovascular event
  • Subjects with vital sign values outside the normal ranges
  • Subjects who are positive for MTB QuantiFERON, hepatitis B surface antigen, hepatitis C virus antibody, severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) by polymerase chain reaction (PCR)/antigen, or human immunodeficiency virus Type I or Type II tests at screening
  • Subjects with signs or symptoms consistent with active viral infection
  • Subjects with baseline eosinophil elevation or a history of urticaria, asthma, allergic dermatitis, food allergy or eosinophilic esophagitis
  • Subjects who have evidence of any bacterial, viral, parasitic, or systemic fungal infections requiring treatment within the 21 days prior to randomization; or hospitalization due to infection within 3 months prior to randomization
  • Subjects who have had any prior investigational treatment with interleukin 2 (IL-2) therapies or have received any investigational agent within five half-lives of the study drug
  • Subjects with a known or suspected sensitivity to products from mammalian cell lines
  • Subjects who have received live vaccines ≤ 2 months prior to screening or any vaccine within the past 14 days
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or F

    Drug: XmAb27564

  • Placebo comparator
    Single Ascending Dose - Placebo Subcutaneous injection of placebo

    Drug: Placebo

Interventions

  • DrugXmAb27564

    Single ascending dose of XmAb27564

  • DrugPlacebo

    Single dose of placebo

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0

    Time frame: Up to Day 45

Secondary outcomes

  1. PK: Area Under the Drug Concentration - Time Curve from Zero to the End of Observation

    Time frame: 45 Days

  2. PK: Maximum Observed Drug Concentration (Cmax) of XmAb27564 after a single dose

    Time frame: 45 Days

  3. PK: Measurement of Cmax

    Time frame: 45 Days

  4. PK: Time to Maximum Plasma Concentration (Tmax) of XmAb27564 after a single dose

    Time frame: 45 Days

  5. PK: Measurement of Tmax

    Time frame: 45 Days

  6. PK: Time to Decrease in Concentration by Half (T1/2) of XmAb27564 after a single dose, due to elimination

    Time frame: 45 Days

  7. PK: Measurement of T1/2

    Time frame: 45 Days

  8. PD: Measurement of Change in Number of Regulatory T Cells

    Time frame: 45 Days

  9. PD: Measurement of Change in Number of Subsets of Conventional T Cells in Blood

    Time frame: 45 Days

  10. PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood

    Time frame: 45 Days

  11. PD: Measurement of Cytokines in Blood

    Time frame: 45 Days

07

Study locations

1 site
  • ICON Early Phase Services, LLC
    San Antonio, Texas 78209, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04857866
Lead sponsor
Xencor, Inc.
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Apr 23, 2021
Start date
Apr 19, 2021
Primary completion
Nov 10, 2022
Completion
Nov 10, 2022
Last update
Mar 1, 2023

Study contacts

Ralph Zitnik, MD
study director · Executive Medical Director, Clinical Development, Xencor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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