Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
Interventions
DRUGTRN-157
DRUGPlacebo
Sponsors
Theron Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject has provided written informed consent 2. The subject is male or female 18 to 65 years of age 3. If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be 4. Non-smoker 5. Good general health 6. Willing to abstain from alcohol, caffeine, and xanthine-containing beverages 7. The subject is compliant and available throughout the entire study period
Exclusion criteria
1. Current diagnosis, as per subject or investigator or screening assessment, of: 1. unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy 2. history of narrow angle glaucoma 3. history of alcohol abuse within the past 5 years 4. history of smoking within the past 6 months 5. positive result for the alcohol and/or drugs of abuse 6. weight \> 100 kg or \< 50 kg 7. clinically significant abnormal ECG 8. history of clinically significant (per the Investigator) disease or disorder 9. any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results 10. Abnormal vital signs defined as any of the following: * Systolic blood pressure ≥ 140 mmHg * Diastolic blood pressure ≥ 90mmHg 2. Heart rate \< 40 or \> 85 beats per minute 3. Fever or other clinically significant physical exam findings 4. Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis 5. History or current symptom(s) of respiratory tract inflammation 6. Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines 7. Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC \< 80% of predicted or FEV1/FVC ratio \< 0.7) 8. FEV1 variability \> 10% between study visits 9. Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding 10. Currently being treated for hypertension or taking any other medications that affect blood pressure significantly 11. Inability to perform acceptable, quality serial spirometry or any other study procedures 12. Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as determined by number of subjects with adverse events | 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of pharmacokinetic parameters | 1 week | Area Under the Plasma Concentration-Time Curve from Zero to the Time of the Last Measurable Concentration (AUC0-t) |
Countries
United States
Outcome results
None listed