Study of STLX-2012 in Healthy Volunteers
ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorStelexis BioSciences
About this trial
The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female participants aged 18-55 years old, inclusive, at Screening.
Body mass index of 18-32 kg/m², inclusive
Healthy as determined by the investigator
Adequate hepatic and renal function
Disqualifiers
Pregnant or lactating female.
Positive urine drug screen or alcohol breath test
Neutropenia, defined as neutrophil count <2.0 x 10^9/L
History of allergic reaction requiring treatment or anaphylactic reactions to any therapeutic drug.
Trial design
Design model
Parallel
Treatments tested in this trial
STLX-2012
DrugSTLX-2012 IV
Placebo
Other interventionPlacebo arm
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: STLX-2012Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of AEs, graded according to the NCI CTCAE Version 6.0
Time frame
56 daysSecondary outcomes
1
Pharmacokinetics of STLX-2012: area under the plasma concentration-time curve (AUC)
Time frame
Day 1 - 292
Pharmacokinetics of STLX-2012: maximum observed serum concentration (Cmax)
Time frame
Day 1 - 293
Pharmacokinetics of STLX-2012: time corresponding to the occurrence of Cmax (Tmax)
Time frame
Day 1 - 294
Pharmacokinetics of STLX-2012: apparent terminal elimination half-life (t½)
Time frame
Day 1 - 29Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: