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: Placebo; Drug: XTMAB-16 2 mg/kg; 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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Single IV Infusion	Drug: Placebo; Single dose of 2 or 4 mg/kg
Experimental: XTMAB-16 2mg/kg; Single IV Infusion	Drug: XTMAB-16 2 mg/kg; Single dose of 2 mg/kg
Experimental: XTMAB-16 4mg/kg; Single IV Infusion	Drug: XTMAB-16 4mg/kg; Single dose of 4 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant With Treatment Emergent Adverse Events (TEAEs)	Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.	Up to day 71

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)	Participants by cohort who test positive for XTMAB-16 ADA	ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)	Participants by cohort who test positive for XTMAB-16 nAb	ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
XTMAB-16 Maximum Observed Concentration (Cmax)	XTMAB-16 (Cmax)	Up to day 71
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1	XTMAB-16 serum (CT) Day 1	Day 1
Time to Maximum Observed Concentration (Tmax) XTMAB-16	Time to maximum observed concentration (tmax) XTMAB-16	PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)	Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞	PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)	Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t	PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Systemic Clearance After IV Dosing (CL)	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) Day 1 up to Day 71		Up to day 71
Mean Residence Time (MRT)	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 25, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

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