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

Xentria

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: XTMAB-16 2 mg/kg; Drug: Placebo; Drug: XTMAB-16 4mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04971395

XTMAB-16-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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25 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single IV Infusion

Treatment:

Drug: Placebo

XTMAB-16 2mg/kg

Experimental group

Description:

Single IV Infusion

Treatment:

Drug: XTMAB-16 2 mg/kg

XTMAB-16 4mg/kg

Experimental group

Description:

Single IV Infusion

Treatment:

Drug: XTMAB-16 4mg/kg