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

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ClinicalTrials.gov Identifier: NCT04857866
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : July 21, 2022
ICON Clinical Research
Information provided by (Responsible Party):
Xencor, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Safety in Healthy Volunteers Drug: XmAb27564 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®27564 in Healthy Volunteers
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : December 23, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or F Drug: XmAb27564
Single ascending dose of XmAb27564

Placebo Comparator: Single Ascending Dose - Placebo Subcutaneous injection of placebo Drug: Placebo
Single dose of placebo

Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0 [ Time Frame: Up to Day 45 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857866

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Contact: Ralph Zitnik, MD 650-996-5321 rzitnik@xencor.com
Contact: Seven Lueder-Powers 858-769-6357 slueder-powers@xencor.com

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United States, Texas
ICON Early Phase Services, LLC Recruiting
San Antonio, Texas, United States, 78209
Contact: Cassandra Key, MD    210-283-4500      
Sponsors and Collaborators
Xencor, Inc.
ICON Clinical Research
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Study Director: Ralph Zitnik, MD Executive Medical Director, Clinical Development, Xencor
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT04857866    
Other Study ID Numbers: XmAb27564-01
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xencor, Inc.:
Healthy Volunteers