Clinical trial NCT04971395: Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Xentria, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.

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.

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.

Primary outcomes:
measure: Participant With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to day 71
Secondary outcomes:
measure: Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
timeFrame: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
measure: Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
timeFrame: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
measure: XTMAB-16 Maximum Observed Concentration (Cmax)
timeFrame: Up to day 71
measure: XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
timeFrame: Day 1
measure: Time to Maximum Observed Concentration (Tmax) XTMAB-16
timeFrame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
measure: 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-∞)
timeFrame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
measure: 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)
timeFrame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
measure: Systemic Clearance After IV Dosing (CL)
timeFrame: Up to day 71
measure: Apparent Terminal Half-life (t1/2)
timeFrame: Up to day 71
measure: Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71
timeFrame: Up to day 71
measure: Mean Residence Time (MRT)
timeFrame: Up to day 71
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Harbor Hospital
state: Maryland
Study officials:
affiliation: Parexel Baltimore Early Phase Clinical Unit
name: Ray Goldwater, MDCM, M.Sc(A), CPI
role: STUDY_DIRECTOR
References: