Single Ascending Dose Study of TRN-157 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: TRN-157

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: TRN-157	Drug: TRN-157

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability as determined by number of subjects with adverse events	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of pharmacokinetic parameters	Area Under the Plasma Concentration-Time Curve from Zero to the Time of the Last Measurable Concentration (AUC0-t)	1 week
Determination of pharmacokinetic parameters	Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-inf)	1 week
Determination of pharmacokinetic parameters	Peak Plasma Concentration (Cmax)	1 week
Determination of pharmacokinetic parameters	Time to Peak Plasma Concentration (tmax)	1 week
Determination of pharmacokinetic parameters	Half-Life (t½)	1 week
Determination of pharmacokinetic parameters	Elimination Rate Constant (kel)	1 week
Determination of pharmacokinetic parameters	Volume of Distribution at Steady State after Non-IV Administration (Vss/F)	1 week
Determination of pharmacokinetic parameters	Total Plasma Clearance after Non-IV Administration (CL/F)	1 week

Collaborators and Investigators

• Sponsor: Theron Pharmaceuticals, Inc.
• Investigators: Study Director: Joe Oren, Theron Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 29, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TRN-157-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No