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
1 other identifier
interventional
30
1 country
1
Brief Summary
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 chronic-obstructive-pulmonary-disease
Started May 2014
Shorter than P25 for phase_1 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 31, 2014
October 1, 2014
3 months
May 5, 2014
October 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability as determined by number of subjects with adverse events
1 week
Secondary Outcomes (8)
Determination of pharmacokinetic parameters
1 week
Determination of pharmacokinetic parameters
1 week
Determination of pharmacokinetic parameters
1 week
Determination of pharmacokinetic parameters
1 week
Determination of pharmacokinetic parameters
1 week
- +3 more secondary outcomes
Study Arms (2)
TRN-157
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Cypress, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joe Oren
Theron Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 8, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
October 31, 2014
Record last verified: 2014-10