Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • TIX100, an orally available inhibitor of thioredoxin-interacting protein

    Drug

    TIX100, an orally available inhibitor of thioredoxin-interacting protein

  • Placebo

    Drug

    placebo

Treatment groups

35 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: TIX100 20 mgActive comparator 1 intervention
Group B: TIX100 60 mgActive comparator 1 intervention
Group C: TIX100 100 mgActive comparator 1 intervention
Group D: TIX100 160 mgActive comparator 1 intervention
Group E: TIX100 200 mgActive comparator 1 intervention
Group F: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
Day 7
2

Number of participants with laboratory analyte results above upper limit of normal.

Time frame
Day 7
3

Number of participants with vital sign results considered clinically significant by the investigator

Time frame
Day 7
4

Number of participants with ECG results considered clinically significant by the investigator

Time frame
Day 7

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TIXiMED, Inc.

Lead sponsor

Source ClinicalTrials.gov
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