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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety in Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04857866

Run by

Xencor, Inc.

People needed

48

Starts

2021-04-19

Expected to finish

2022-11-10

Last updated by the study team

2023-03-01

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ICON Early Phase Services, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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