Clinical trial NCT02133339: Single Ascending Dose Study of TRN-157 in Healthy Subjects
Official title: A Phase I, Randomized, Double-blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of Nebulized, TRN-157 Inhalation Solution in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Theron Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability as determined by number of subjects with adverse events
timeFrame: 1 week
Secondary outcomes:
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
measure: Determination of pharmacokinetic parameters
timeFrame: 1 week
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
Study officials:
affiliation: Theron Pharmaceuticals, Inc.
name: Joe Oren
role: STUDY_DIRECTOR
References: