Phase 1 N=25 Randomized Double-blind Other

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

Healthy Participants

Bottom Line

View on ClinicalTrials.gov: NCT04971395 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Jan 2025

Primary outcome: Primary: Participant With Treatment Emergent Adverse Events (TEAEs) — 2; 3; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Drug); XTMAB-16 2 mg/kg (Drug); XTMAB-16 4mg/kg (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Xentria, Inc.
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant With Treatment Emergent Adverse Events (TEAEs)	2; 3; 1	—
SECONDARY Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)	0; 0; 0; 0; 0; 0	—
SECONDARY Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)	1; 0; 0; 3; 0; 0	—
SECONDARY XTMAB-16 Maximum Observed Concentration (Cmax)	64.17; 131	—
SECONDARY XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1	62.18; 128.9	—
SECONDARY Time to Maximum Observed Concentration (Tmax) XTMAB-16	2.16; 3.0	—
SECONDARY 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-∞)	601.5; 1249	—
SECONDARY 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)	525.2; 1224	—
SECONDARY Systemic Clearance After IV Dosing (CL)	0.2498; 0.2449	—
SECONDARY Apparent Terminal Half-life (t1/2)	8.644; 10.23	—
SECONDARY Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71	2.864; 3.435	—
SECONDARY Mean Residence Time (MRT)	12.51; 13.32	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04971395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.