A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTIXiMED, Inc.
About this trial
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Eligibility criteria
Qualifiers
Subjects aged 18-70 years, both genders.
Absence of clinically significant illness or surgery within the preceding 12 weeks.
Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
Disqualifiers
History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen.
Pregnant or breastfeeding within six months of screening assessment.
Substantial changes in eating habits or exercise routine within the preceding three months.
Evidence of eating disorders.
Trial design
Treatments tested in this trial
- TIX100, an orally available inhibitor of thioredoxin-interacting protein
- Placebo
Treatment groups
35 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov