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

NCT04857866 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: XmAb27564-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety in Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  Up to Day 45

Secondary Outcomes (11)

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

  45 Days

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

  45 Days

• PK: Measurement of Cmax

  45 Days

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

  45 Days

• PK: Measurement of Tmax

  45 Days

Study Arms (2)

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

EXPERIMENTAL

Drug: XmAb27564

Single Ascending Dose - Placebo Subcutaneous injection of placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XmAb27564 DRUG

Single ascending dose of XmAb27564

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

Placebo DRUG

Single dose of placebo

Single Ascending Dose - Placebo Subcutaneous injection of placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Xencor, Inc.: lead
• ICON Clinical Research: collaborator

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

Study Officials

• Ralph Zitnik, MD

  Executive Medical Director, Clinical Development, Xencor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: April 19, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

US (1)