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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2022-03-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Single IV Infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of 2 or 4 mg/kg

XTMAB-16 2mg/kg

Single IV Infusion

Group Type EXPERIMENTAL

XTMAB-16 2 mg/kg

Intervention Type DRUG

Single dose of 2 mg/kg

XTMAB-16 4mg/kg

Single IV Infusion

Group Type EXPERIMENTAL

XTMAB-16 4mg/kg

Intervention Type DRUG

Single dose of 4 mg/kg

Interventions

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Placebo

Single dose of 2 or 4 mg/kg

Intervention Type DRUG

XTMAB-16 2 mg/kg

Single dose of 2 mg/kg

Intervention Type DRUG

XTMAB-16 4mg/kg

Single dose of 4 mg/kg

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes