Status:
COMPLETED
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
Lead Sponsor:
Xencor, Inc.
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Safety in Healthy Volunteers
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
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.
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 mutei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04857866
Start Date
April 19 2021
End Date
November 10 2022
Last Update
March 1 2023
Active Locations (1)
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1
ICON Early Phase Services, LLC
San Antonio, Texas, United States, 78209