At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
XTMAB-16 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Placebo, XTMAB-16 2 mg/kg, and 1 other intervention for Healthy Participants. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartJun 2021
First PostedJul 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedJul 21, 2021
Enrollment StartJun 25, 2021
Primary CompletionMar 18, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.9 years ago
Interventions
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