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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971395
• Other study ID #: XTMAB-16-101
• Status: Completed
• Phase: Phase 1
• Start date: June 25, 2021
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2022
• Source: Xentria, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• XTMAB-16 2mg/kg
Biological XTMAB-16 IV infusion single dose
• Placebo
Placebo; IV infusion single dose
• XTMAB-16 4mg/kg
Biological XTMAB-16 IV infusion single dose

Locations

Country	Name	City	State
United States	MedStar Harbor Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Xentria, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Safety and Tolerability]		Up to day 71
Secondary	Incidence of participants by cohort who test positive for XTMAB-16 ADA		Up to day 71
Secondary	Incidence of participants by cohort who test positive for XTMAB-16 nAb		Up to day 71
Secondary	Maximum observed XTMAB-16 concentration (Cmax)		Up to day 71
Secondary	XTMAB-16 serum concentration at the end of drug infusion (CT)		Up to day 71
Secondary	Time to maximum observed XTMAB-16 concentration (tmax)		Up to day 71
Secondary	Area under the XTMAB-16 concentration-time curve from time zero (predose) extrapolated to infinity (AUC0-8)		Up to day 71
Secondary	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
Secondary	Systemic clearance after IV dosing (CL)		Up to day 71
Secondary	Apparent terminal half-life (t1/2)		Up to day 71
Secondary	Volume of distribution following IV dosing (Vz)		Up to day 71
Secondary	Mean residence time (MRT)		Up to day 71