Single Ascending Dose Study of TRN-157 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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

Key facts

Study ID

NCT02133339

Run by

Theron Pharmaceuticals, Inc.

People needed

30

Starts

2014-05-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject has provided written informed consent
• The subject is male or female 18 to 65 years of age
• If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
• Non-smoker
• Good general health
• Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
• The subject is compliant and available throughout the entire study period

You may not qualify if…

• Current diagnosis, as per subject or investigator or screening assessment, of:
• unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
• history of narrow angle glaucoma
• history of alcohol abuse within the past 5 years
• history of smoking within the past 6 months
• positive result for the alcohol and/or drugs of abuse
• weight > 100 kg or < 50 kg
• clinically significant abnormal ECG
• history of clinically significant (per the Investigator) disease or disorder
• any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
• Abnormal vital signs defined as any of the following:
• Systolic blood pressure ≥ 140 mmHg
• Diastolic blood pressure ≥ 90mmHg
• Heart rate < 40 or > 85 beats per minute
• Fever or other clinically significant physical exam findings
• Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
• History or current symptom(s) of respiratory tract inflammation
• Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
• Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
• FEV1 variability > 10% between study visits
• Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
• Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
• Inability to perform acceptable, quality serial spirometry or any other study procedures
• Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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