CompletedNCT04971395Updated Jan 14, 2025Results posted

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

A Phase 1 interventional study of Placebo and XTMAB-16 2 mg/kg in Healthy Participants, sponsored by Xentria, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Healthy Participants

In context

Lead sponsor

Xentria, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 25 participants (actual)

Study arms

Placebo comparator
Placebo
Single IV Infusion
Drug: Placebo
Experimental
XTMAB-16 2mg/kg
Single IV Infusion
Drug: XTMAB-16 2 mg/kg
Experimental
XTMAB-16 4mg/kg
Single IV Infusion
Drug: XTMAB-16 4mg/kg

Interventions

DrugPlacebo
Single dose of 2 or 4 mg/kg
DrugXTMAB-16 2 mg/kg
Single dose of 2 mg/kg
DrugXTMAB-16 4mg/kg
Single dose of 4 mg/kg

What researchers measure

Primary outcomes

Participant With Treatment Emergent Adverse Events (TEAEs)
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
Time frame: Up to day 71

Secondary outcomes

Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Participants by cohort who test positive for XTMAB-16 ADA
Time frame: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Participants by cohort who test positive for XTMAB-16 nAb
Time frame: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
XTMAB-16 Maximum Observed Concentration (Cmax)
XTMAB-16 (Cmax)
Time frame: Up to day 71
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
XTMAB-16 serum (CT) Day 1
Time frame: Day 1
Time to Maximum Observed Concentration (Tmax) XTMAB-16
Time to maximum observed concentration (tmax) XTMAB-16
Time frame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
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-∞)
Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞
Time frame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
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)
Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t
Time frame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Systemic Clearance After IV Dosing (CL)
Systemic clearance after IV dosing (CL)
Time frame: Up to day 71
Apparent Terminal Half-life (t1/2)
Time frame: Up to day 71
Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71
Time frame: Up to day 71
Mean Residence Time (MRT)
Mean residence time (MRT)
Time frame: Up to day 71

Results

Posted Jan 14, 2025

Participant flow

Participant flow — Overall Study
Milestone	Pooled Placebo	Single IV Infusion of 2 mg/kg of XTMAB-16	Single IV Infusion of 4 mg/kg of XTMAB-16
Started	6	10	9
Completed	6	9	9
Not completed	0	1	0
Withdrew: Withdrawal by subject	0	1	0

Outcome measures

PrimaryParticipant With Treatment Emergent Adverse Events (TEAEs)

Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.

Time frame:: Up to day 71
Reported as:: Count of participants · Participants

Participant With Treatment Emergent Adverse Events (TEAEs)
Participants	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16	Pooled Placebo
Participant With Treatment Emergent Adverse Events (TEAEs)	2	3	1

SecondaryParticipants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)

Participants by cohort who test positive for XTMAB-16 ADA

Time frame:: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
Reported as:: Count of participants · Participants

Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Participants	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Day 1 ADA Screening	0	0
Day 8 ADA Screening	0	0
Day 15 ADA Screening	1	1
Day 15 ADA Confirmatory	0	0
Day 29 ADA Screening	1	0
Day 29 ADA Confirmatory	1	0
Day 43 ADA Screening	4	0
Day 43 ADA Confirmatory	3	0
Day 57 ADA Screening	6	1
Day 57 ADA Confirmatory	5	1
Day 71 ADA Screening	6	3
Day 71 ADA Confirmatory	6	2

SecondaryParticipants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)

Participants by cohort who test positive for XTMAB-16 nAb

Time frame:: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
Reported as:: Count of participants · Participants

Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Participants	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Day 29	1	0
Day 43	3	0
Day 57	5	1
Day 71	6	2

SecondaryXTMAB-16 Maximum Observed Concentration (Cmax)

XTMAB-16 (Cmax)

Time frame:: Up to day 71
Reported as:: Mean · Cmax (μg/mL)

XTMAB-16 Maximum Observed Concentration (Cmax)
Cmax (μg/mL)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
XTMAB-16 Maximum Observed Concentration (Cmax)	64.17 ± 9.94	131 ± 23.42

SecondaryXTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1

XTMAB-16 serum (CT) Day 1

Time frame:: Day 1
Reported as:: Mean · CT (μg/mL)

XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
CT (μg/mL)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1	62.18 ± 6.757	128.9 ± 22.39

SecondaryTime to Maximum Observed Concentration (Tmax) XTMAB-16

Time to maximum observed concentration (tmax) XTMAB-16

Time frame:: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Reported as:: Median · tmax (h)

Time to Maximum Observed Concentration (Tmax) XTMAB-16
tmax (h)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Time to Maximum Observed Concentration (Tmax) XTMAB-16	2.16 (2.1 to 8.65)	3.0 (2.12 to 8.02)

SecondaryArea 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-∞)

Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞

Time frame:: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Reported as:: Mean · AUC0-inf (day*μg/mL)

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-∞)
AUC0-inf (day*μg/mL)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
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 ± 231.8	1249 ± 245.0

SecondaryArea 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)

Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t

Time frame:: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Reported as:: Mean · AUC0-last (day*μg/mL)

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)
AUC0-last (day*μg/mL)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
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 ± 238.0	1224 ± 235.9

SecondarySystemic Clearance After IV Dosing (CL)

Systemic clearance after IV dosing (CL)

Time frame:: Up to day 71
Reported as:: Mean · CL (L/day)

Systemic Clearance After IV Dosing (CL)
CL (L/day)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Systemic Clearance After IV Dosing (CL)	0.2498 ± 0.04883	0.2449 ± 0.06064

SecondaryApparent Terminal Half-life (t1/2)

Time frame:: Up to day 71
Reported as:: Mean · t1/2 (day)

Apparent Terminal Half-life (t1/2)
t1/2 (day)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Apparent Terminal Half-life (t1/2)	8.644 ± 4.726	10.23 ± 3.617

SecondaryVolume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71

Time frame:: Up to day 71
Reported as:: Mean · Vz (L)

Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71
Vz (L)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71	2.864 ± 0.8861	3.435 ± 0.9878

SecondaryMean Residence Time (MRT)

Mean residence time (MRT)

Time frame:: Up to day 71
Reported as:: Mean · MRT (day)

Mean Residence Time (MRT)
MRT (day)	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16
Mean Residence Time (MRT)	12.51 ± 6.214	13.32 ± 3.794

Adverse events

Collected over The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2 mg/kg XTMAB-16	0/10 (0%)	0/10 (0%)	3/10 (30%)
4 mg/kg XTMAB-16	0/9 (0%)	1/9 (11.1%)	4/9 (44.4%)
Pooled Placebo	0/6 (0%)	0/6 (0%)	2/6 (33.3%)

Most frequent serious events

Most frequent serious events
Event	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16	Pooled Placebo
abdominal painGastrointestinal disorders	0/10	1/9	0/6

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	2 mg/kg XTMAB-16	4 mg/kg XTMAB-16	Pooled Placebo
HeadacheNervous system disorders	1/10	2/9	0/6
Abdominal PainGastrointestinal disorders	0/10	2/9	0/6
Nasal CongestionRespiratory, thoracic and mediastinal disorders	0/10	2/9	0/6
Dry MouthGastrointestinal disorders	0/10	1/9	1/6
Eye Pain due to Covid TestingEye disorders	0/10	0/9	1/6
FatigueGeneral disorders	1/10	1/9	0/6
Decreased AppetiteMetabolism and nutrition disorders	1/10	1/9	0/6
BloatingGastrointestinal disorders	0/10	1/9	0/6
ConstipationGastrointestinal disorders	0/10	1/9	0/6
DehydrationMetabolism and nutrition disorders	0/10	1/9	0/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Single IV Infusion of 2 mg/kg of XTMAB-16	Single IV Infusion of 4 mg/kg of XTMAB-16	Pooled Placebo	Total
<=18 years	0	0	0	0
Between 18 and 65 years	10	9	6	25
>=65 years	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Single IV Infusion of 2 mg/kg of XTMAB-16	Single IV Infusion of 4 mg/kg of XTMAB-16	Pooled Placebo	Total
Female	7	6	3	16
Male	3	3	3	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Single IV Infusion of 2 mg/kg of XTMAB-16	Single IV Infusion of 4 mg/kg of XTMAB-16	Pooled Placebo	Total
Hispanic or Latino	2	2	2	6
Not Hispanic or Latino	8	7	4	19
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Single IV Infusion of 2 mg/kg of XTMAB-16	Single IV Infusion of 4 mg/kg of XTMAB-16	Pooled Placebo	Total
American Indian or Alaska Native	1	0	0	1
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	8	8	4	20
White	1	1	2	4
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

1 site

MedStar Harbor Hospital
Baltimore, Maryland 21225, United States

References and documents

Study documents

Study protocol · May 28, 2021
Statistical analysis plan · Mar 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04971395
Lead sponsor: Xentria, Inc.
Responsible party: Sponsor
First posted: Jul 21, 2021
Start date: Jun 25, 2021
Primary completion: Mar 18, 2022
Completion: Mar 18, 2022
Results posted: Jan 14, 2025
Last update: Jan 14, 2025

Study contacts

Ray Goldwater, MDCM, M.Sc(A), CPI

study director · Parexel Baltimore Early Phase Clinical Unit

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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