Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants

A Randomized, Double-blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: XTMAB-16 2mg/kg; Drug: Placebo; Drug: XTMAB-16 4mg/kg

Detailed Description

A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • MedStar Harbor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• The participant is a healthy adult male or female aged 18 to 45 years, inclusive, at the time of informed consent.
• The participant weighs between 45 kg (99 lbs) and 100 kg (220 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the time of informed consent.
• The participant agrees to use highly effective method of contraception from the time of signing consent throughout 90 days after dosing.

Key Exclusion Criteria:

• The participant has received any investigational compound within 90 days before dosing.
• The participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect the participant's safety, increase risk of seizure or lower the seizure threshold, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance of any conditions the participant may have; however, consultation with the Xentria Medical Monitor may be warranted.
• The participant has a known hypersensitivity to any component of the formulation of XTMAB-16.
• The participant has a positive result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Baseline (Day -2).
• The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single IV infusion of 2 mg/kg of XTMAB-16 or placebo; Sentinel group: Each cohort will have a sentinel group of 2 participants (1:1 XTMAB-16 and placebo, respectively). dosed at least 48 hours before the remaining participants in the same cohort. (Up to 99 days) After safety is confirmed, the remaining patients within the same cohort will be dosed. Remaining group: Each cohort will then enroll 10 participants (8:2 XTMAB-16 and placebo, respectively) (Up to 99 days)	Drug: XTMAB-16 2mg/kg; Biological XTMAB-16 IV infusion single dose; Drug: Placebo; Placebo; IV infusion single dose
Experimental: Single IV infusion of 4 mg/kg of XTMAB-16 or placebo; Sentinel group: Each cohort will have a sentinel group of 2 participants (1:1 XTMAB-16 and placebo, respectively). dosed at least 48 hours before the remaining participants in the same cohort. (Up to 99 days) After safety is confirmed, the remaining patients within the same cohort will be dosed. Remaining group: Each cohort will then enroll 10 participants (8:2 XTMAB-16 and placebo, respectively) (Up to 99 days)	Drug: Placebo; Placebo; IV infusion single dose; Drug: XTMAB-16 4mg/kg; Biological XTMAB-16 IV infusion single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Safety and Tolerability]	Up to day 71

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of participants by cohort who test positive for XTMAB-16 ADA	Up to day 71
Incidence of participants by cohort who test positive for XTMAB-16 nAb	Up to day 71
Maximum observed XTMAB-16 concentration (Cmax)	Up to day 71
XTMAB-16 serum concentration at the end of drug infusion (CT)	Up to day 71
Time to maximum observed XTMAB-16 concentration (tmax)	Up to day 71
Area under the XTMAB-16 concentration-time curve from time zero (predose) extrapolated to infinity (AUC0-∞)	Up to day 71
Area under the XTMAB-16 concentration-time-curve from time zero to (predose) to the last quantifiable time point at t (AUC0-t)	Up to day 71
Systemic clearance after IV dosing (CL)	Up to day 71
Apparent terminal half-life (t1/2)	Up to day 71
Volume of distribution following IV dosing (Vz)	Up to day 71
Mean residence time (MRT)	Up to day 71

Collaborators and Investigators

• Sponsor: Xentria, Inc.
• Investigators: Study Director: Ray Goldwater, MDCM, M.Sc(A), CPI, Parexel Baltimore Early Phase Clinical Unit

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: XTMAB-16-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No