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Single Ascending Dose Study of TRN-157 in Healthy Subjects

NCT ID: NCT02133339

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRN-157

Group Type EXPERIMENTAL

TRN-157

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TRN-157

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theron Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joe Oren

Role: STUDY_DIRECTOR

Theron Pharmaceuticals, Inc.

Locations

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Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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TRN-157-101

Identifier Type: -

Identifier Source: org_study_id