Healthy ParticipantsPhase 1NCT04971395
Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
A Phase 1 study testing XTMAB-16 2 mg/kg and XTMAB-16 4mg/kg in people with Healthy Participants, run by Xentria, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- XTMAB-16 2 mg/kg and XTMAB-16 4mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2021to 18 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Healthy Participants
- Being tested
- Placebo, XTMAB-16 2 mg/kg, XTMAB-16 4mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose of 2 or 4 mg/kg
XTMAB-16 2 mg/kgDrug
Single dose of 2 mg/kg
XTMAB-16 4mg/kgDrug
Single dose of 4 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single IV Infusion Receives: Drug: Placebo |
| XTMAB-16 2mg/kg | Experimental | Single IV Infusion Receives: Drug: XTMAB-16 2 mg/kg |
| XTMAB-16 4mg/kg | Experimental | Single IV Infusion Receives: Drug: XTMAB-16 4mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant With Treatment Emergent Adverse Events (TEAEs)
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
Measured: Up to day 71
Secondary outcomes (11)
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Participants by cohort who test positive for XTMAB-16 ADA
Measured: 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
Measured: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
XTMAB-16 Maximum Observed Concentration (Cmax)
XTMAB-16 (Cmax)
Measured: Up to day 71
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
XTMAB-16 serum (CT) Day 1
Measured: Day 1
Time to Maximum Observed Concentration (Tmax) XTMAB-16
Time to maximum observed concentration (tmax) XTMAB-16
Measured: 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-∞
Measured: 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
Measured: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
Systemic Clearance After IV Dosing (CL)
Systemic clearance after IV dosing (CL)
Measured: Up to day 71
Apparent Terminal Half-life (t1/2)
Measured: Up to day 71
Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71
Measured: Up to day 71
Mean Residence Time (MRT)
Mean residence time (MRT)
Measured: Up to day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start25 Jun 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ray Goldwater, MDCM, M.Sc(A), CPI, Study director, Parexel Baltimore Early Phase Clinical Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971395
- Sponsor's protocol ID
- XTMAB-16-101
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2021
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04971395
- Acronym / sponsor ID
- XTMAB-16-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle IV Infusion |
| XTMAB-16 2mg/kg | Experimental | Drug: XTMAB-16 2 mg/kgSingle IV Infusion |
| XTMAB-16 4mg/kg | Experimental | Drug: XTMAB-16 4mg/kgSingle IV Infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSingle dose of 2 or 4 mg/kg | Drug | Placebo |
| XTMAB-16 2 mg/kgSingle dose of 2 mg/kg | Drug | XTMAB-16 2mg/kg |
| XTMAB-16 4mg/kgSingle dose of 4 mg/kg | Drug | XTMAB-16 4mg/kg |
Primary outcome
Participant With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to day 71
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
11 secondary outcomes
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (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)
Time frame: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71
XTMAB-16 Maximum Observed Concentration (Cmax)
Time frame: Up to day 71
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
Time frame: Day 1
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-∞)
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)
Time frame: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71
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)
Time frame: Up to day 71
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray Goldwater, MDCM, M.Sc(A), CPI study director
Parexel Baltimore Early Phase Clinical Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XTMAB-16 2 mg/kg and XTMAB-16 4mg/kg in people with Healthy Participants, run by Xentria, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.