Chronic Obstructive Pulmonary DiseasePhase 1NCT02133339
Single Ascending Dose Study of TRN-157 in Healthy Subjects
A Phase 1 study testing TRN-157 in people with Chronic Obstructive Pulmonary Disease, run by Theron Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TRN-157
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TRN-157, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRN-157Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TRN-157 | Experimental | Not described Receives: Drug: TRN-157 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by number of subjects with adverse events
Measured: 1 week
Secondary outcomes (8)
Determination of pharmacokinetic parameters
Area Under the Plasma Concentration-Time Curve from Zero to the Time of the Last Measurable Concentration (AUC0-t)
Measured: 1 week
Determination of pharmacokinetic parameters
Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-inf)
Measured: 1 week
Determination of pharmacokinetic parameters
Peak Plasma Concentration (Cmax)
Measured: 1 week
Determination of pharmacokinetic parameters
Time to Peak Plasma Concentration (tmax)
Measured: 1 week
Determination of pharmacokinetic parameters
Half-Life (t½)
Measured: 1 week
Determination of pharmacokinetic parameters
Elimination Rate Constant (kel)
Measured: 1 week
Determination of pharmacokinetic parameters
Volume of Distribution at Steady State after Non-IV Administration (Vss/F)
Measured: 1 week
Determination of pharmacokinetic parameters
Total Plasma Clearance after Non-IV Administration (CL/F)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theron Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Oren, Study director, Theron Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133339
- Sponsor's protocol ID
- TRN-157-101
- Status last verified
- Oct 2014
- First submitted
- 5 May 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02133339
- Acronym / sponsor ID
- TRN-157-101
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Theron Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRN-157 | Experimental | Drug: TRN-157 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- Current diagnosis, as per subject or investigator or screening assessment, of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRN-157 | Drug | TRN-157 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability as determined by number of subjects with adverse events
Time frame: 1 week
8 secondary outcomes
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Determination of pharmacokinetic parameters
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Oren study director
Theron Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRN-157 in people with Chronic Obstructive Pulmonary Disease, run by Theron Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as determined by number of subjects with adverse events (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.