Actively Recruiting
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects
Led by TIXiMED, Inc. · Updated on 2025-01-30
35
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
CONDITIONS
Official Title
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, male or female
- Healthy based on medical history, physical exam, vital signs, lab tests, cardiac and respiratory assessments
- No significant illness or surgery within prior 12 weeks
- No history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- Males with female partners of childbearing potential must agree to use condoms during the study
- Females of childbearing potential must have negative pregnancy tests and agree to use double-barrier contraception
- Females of non-childbearing potential (e.g., tubal ligation, hysterectomy, postmenopausal) are eligible
- Body mass index between 18.5 and 29.9 kg/m2
- Hemoglobin A1c less than 6.0%
You will not qualify if you...
- History of excessive alcohol use (>21 drinks/week for males, >14 drinks/week for females) or recent recreational drug use or abuse
- Pregnant or breastfeeding within 6 months of screening
- Major changes in diet or exercise in past 3 months
- Evidence of eating disorders
- Weight change greater than 5% in past 3 months
- Bariatric surgery within past 5 years
- Significant kidney impairment (eGFR <60 mL/min/1.73m2)
- Liver function tests more than twice the normal limit on repeated measures
- Diseases affecting metabolism or eating behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression)
- Use of drugs approved for obesity treatment
- Any significant abnormal findings on physical exam or lab tests
- Prolonged QT/QTc interval >450 ms or history of serious cardiac events or family history of Long QT Syndrome
- Participation in another investigational drug trial within 3 months prior to this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ProSciento, Inc.
Chula Vista, California, United States, 91911
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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