Single Ascending Dose Study of TRN-157 in Healthy Subjects

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: TRN-157; Drug: Placebo

• Registration Number: NCT02133339
• Lead Sponsor: Theron Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRN-157	TRN-157	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as determined by number of subjects with adverse events	1 week

Secondary Outcome Measures

Name	Time	Method
Determination of pharmacokinetic parameters	1 week	Total Plasma Clearance after Non-IV Administration (CL/F)