Single Ascending Dose Study of TRN-157 in Healthy Subjects

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133339
• Other study ID #: TRN-157-101
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2014
• Last updated: October 29, 2014
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Theron Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TRN-157

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Theron Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as determined by number of subjects with adverse events		1 week	Yes
Secondary	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	Yes
Secondary	Determination of pharmacokinetic parameters	Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-inf)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Peak Plasma Concentration (Cmax)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Time to Peak Plasma Concentration (tmax)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Half-Life (t½)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Elimination Rate Constant (kel)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Volume of Distribution at Steady State after Non-IV Administration (Vss/F)	1 week	Yes
Secondary	Determination of pharmacokinetic parameters	Total Plasma Clearance after Non-IV Administration (CL/F)	1 week	Yes