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| Name | Class |
|---|---|
| European Commission | OTHER |
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A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.
The purpose of this study is to evaluate the safety, tolerability, and to determine the pharmacokinetics of QR-010 administered via inhalation in adult homozygous for ΔF508 Cystic Fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QR-010 | Experimental | QR-010 administered via inhalation either as a single dose or three times weekly for four weeks. |
|
| Placebo | Placebo Comparator | Placebo (normal saline) administered via inhalation either as a single dose or three times weekly for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QR-010 | Drug | Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Subjects Experiencing Treatment Emergent Adverse Events From Baseline Through End of Study | Number of subjects experiencing at least one treatment emergent adverse events (TEAEs) | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Severity of Treatment Emergent Adverse Events From Baseline Through End of Study | Assessment of severity of treatment emergent adverse events (TEAEs). Severity is graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Modified for CF (CTCAE v4.03). For events not present in this listing the following grading was applied: Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate: Minimal, local, or noninvasive intervention indicated; discomfort sufficient to reduce or interfere with daily activities; Severe: Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization may be indicated; disabling; limits self-care with significant interference with daily activities; incapacitating with inability to perform self care activities of daily living; Life-threatening: Urgent intervention indicated; immediate risk of death. | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Incidence of Subjects Experiencing Dose-Limiting Toxicities (DLT) in Each Dose Cohort From Baseline Through End of Study Visit. | DLT's were defined as an allergic reaction, acute bronchospasm or acute AEs of interest requiring (immediate) medical intervention. | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Abnormalities Reported Regarding Laboratory Parameters, Vital Signs, ECG, Spirometry, and Physical Findings. | Number of subjects experiencing at least one abnormality for the categories laboratory parameters, vital signs, ECG, spirometry and physical findings that were reported as treatment emergent adverse event with a relationship to study drug as either possibly, probably or definitely. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in CFQ-R RSS | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Elborn, MD | Trust and Queen's University Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California USC - Keck School of Medicine | Los Angeles | California | 90033 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31215818 | Derived | Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. |
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The enrollment of this clinical trial followed a staggered approach; a new SAD cohort was enrolled following review of the previous SAD cohort. The first MAD cohort opened following the review of the first two SAD cohorts. Subsequent MAD dosing cohorts were initiated following review of the corresponding supportive SAD and MAD cohorts.
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| ID | Title | Description |
|---|---|---|
| FG000 | QR-010 SAD 6.25mg | QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation |
| FG001 | QR-010 SAD 12.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single Ascending Dose (SAD) Cohorts |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2017 | Oct 22, 2018 |
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| Placebo | Drug | Normal Saline |
|
| 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Maximum Serum Concentration | Cmax: QR-010 maximum serum concentrations | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Time to Maximum Serum Concentration | Tmax: Time to Cmax of QR-010 serum concentrations. | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Terminal Half-life (T1/2) | The terminal elimination half-life will be estimated by non-linear regression analysis of the terminal elimination slope | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Area Under the Curve to Final Sample [AUC(0-last)] | Area under the curve to the final sample with a concentration greater than lower limit of quantification (LLQ) will be calculated using the linear trapezoidal method | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Area Under the Curve to Infinity [AUC(0-∞)] | AUC0-∞: Area under the curve to infinity will be calculated based on the last observed concentration Clast(obs) using formula: AUC0-∞=AUClast+Clast(obs)/λz | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Serum Clearance (CL) | CL: Serum clearance will be estimated using the formula: CL = Dose/AUC0-∞. | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in CFQ-R RSS (Subgroup ppFEV1 <90% at Baseline) | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline) | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in ppFEV1 | Exploratory efficacy parameter, as measured by spirometry, and expressed in percent predicted FEV1 (ppFEV1). Mean values reported refer to ''adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1 (ppFEV1). Mean values reported refer to''difference vs placebo in adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in ppFEV1 (Subgroup ppFEV1 <90% at Baseline) | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline) | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values. | Day 15, Day 33, Day 54 |
| Stanford University |
| Palo Alto |
| California |
| 940304 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1032 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 66160 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6522 | United States |
| Universitair Ziekenhuis Brussel | Brussels | 01090 | Belgium |
| University of Leuven | Leuven | 03000 | Belgium |
| University of Calgary (Health Sciences Centre) | Calgary | Alberta | T2N 4N1 | Canada |
| Motol University Hospital | Prague | 15006 | Czechia |
| Cystic Fibrosis Center Rigshospitalet | Copenhagen | 02100 | Denmark |
| HGRL Chu Nantes | Nantes | 44300 | France |
| Hopital Necker- Enfants Malades | Paris | 75743 | France |
| Charité Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Munich U. Hospital, Cystic Fibrosis Center for Adults | Munich | 80336 | Germany |
| Azienda Ospedaliera Universitaria Integrata di Verona | Verona | 37134 | Italy |
| Hospital Vall D'Hebron | Barcelona | 08035 | Spain |
| Celerion | Belfast | Northern Ireland | BT9 6AD | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation
| FG002 | QR-010 SAD 25 mg | QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation |
| FG003 | QR-010 SAD 50 mg | QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation |
| FG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| FG005 | QR-010 MAD 6.25 | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation. |
| FG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation. |
| FG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation. |
| FG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation. |
| FG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
| COMPLETED |
|
| NOT COMPLETED |
|
| Multiple Ascending Dose (MAD) Cohorst |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QR-010 SAD 6.25 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG001 | QR-010 SAD 12.5 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG002 | QR-010 SAD 25 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG003 | QR-010 SAD 50 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| BG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| BG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| FEV1 | Lung function; forced expiratory volume in 1 second | Mean | Standard Deviation | L |
| ||||||||||||||
| ppFEV1 | Lung function; percent predicted Forced Expiratory Volume in 1 second | Mean | Standard Deviation | percent |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Subjects Experiencing Treatment Emergent Adverse Events From Baseline Through End of Study | Number of subjects experiencing at least one treatment emergent adverse events (TEAEs) | All subjects who received either QR-010 or placebo | Posted | Count of Participants | Participants | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Severity of Treatment Emergent Adverse Events From Baseline Through End of Study | Assessment of severity of treatment emergent adverse events (TEAEs). Severity is graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Modified for CF (CTCAE v4.03). For events not present in this listing the following grading was applied: Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate: Minimal, local, or noninvasive intervention indicated; discomfort sufficient to reduce or interfere with daily activities; Severe: Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization may be indicated; disabling; limits self-care with significant interference with daily activities; incapacitating with inability to perform self care activities of daily living; Life-threatening: Urgent intervention indicated; immediate risk of death. | All subjects who received either QR-010 or placebo. | Posted | Count of Participants | Participants | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Subjects Experiencing Dose-Limiting Toxicities (DLT) in Each Dose Cohort From Baseline Through End of Study Visit. | DLT's were defined as an allergic reaction, acute bronchospasm or acute AEs of interest requiring (immediate) medical intervention. | All subjects who received either QR-010 or placebo. There were no Dose Limiting Toxicities (DLTs) reported in the SAD or MAD cohorts. | Posted | Count of Participants | Participants | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Abnormalities Reported Regarding Laboratory Parameters, Vital Signs, ECG, Spirometry, and Physical Findings. | Number of subjects experiencing at least one abnormality for the categories laboratory parameters, vital signs, ECG, spirometry and physical findings that were reported as treatment emergent adverse event with a relationship to study drug as either possibly, probably or definitely. | All subjects who received either QR-010 or placebo. | Posted | Count of Participants | Participants | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration | Cmax: QR-010 maximum serum concentrations | Study population included all subjects treated either with QR-010 or placebo. Quantifiable serum concentrations are only available for the 50mg SAD and 50 mg MAD cohorts. | Posted | Mean | Standard Deviation | ng/mL | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Serum Concentration | Tmax: Time to Cmax of QR-010 serum concentrations. | Population included all subjects treated with either QR-010 or placebo. Quantifiable serum concentrations are only available for the 50mg SAD and MAD cohorts. | Posted | Median | Full Range | hour | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life (T1/2) | The terminal elimination half-life will be estimated by non-linear regression analysis of the terminal elimination slope | The terminal half-life is not reported because the %AUC (Area Under the Curve) extrapolation was too large. | Posted | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve to Final Sample [AUC(0-last)] | Area under the curve to the final sample with a concentration greater than lower limit of quantification (LLQ) will be calculated using the linear trapezoidal method | Quantifiable serum concentrations are only available for the 50mg SAD and MAD cohort. For the PK parameters of the SAD 6.25, 12.5 and 25mg cohorts, no quantifiable serum concentrations could be measured. For the 6.25, 12.5 and 25mg MAD cohorts, no PK profiling was performed due to the large number of samples below the limit of detection. | Posted | Mean | Standard Deviation | ng.hr/mL | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve to Infinity [AUC(0-∞)] | AUC0-∞: Area under the curve to infinity will be calculated based on the last observed concentration Clast(obs) using formula: AUC0-∞=AUClast+Clast(obs)/λz | The Area Under the Curve to Infinity is not reported because the %AUC extrapolation was too large | Posted | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Clearance (CL) | CL: Serum clearance will be estimated using the formula: CL = Dose/AUC0-∞. | The Serum Clearance is not reported because the %AUC extrapolation was too large. | Posted | 8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in CFQ-R RSS | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses. For 1 subject in the placebo group no data were available at Day 54. "Mean" in this table refers to "Adjusted Mean". | Posted | Mean | Standard Error | score on a scale | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses. | Posted | Mean | Standard Error | score on a scale | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in CFQ-R RSS (Subgroup ppFEV1 <90% at Baseline) | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values. | Subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at baseline. For 1 subject in the placebo group no data were available at Day 54. "Mean" in this table refers to "Adjusted Mean". | Posted | Mean | Standard Error | score on a scale | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline) | Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline. | Posted | Mean | Standard Error | score on a scale | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in ppFEV1 | Exploratory efficacy parameter, as measured by spirometry, and expressed in percent predicted FEV1 (ppFEV1). Mean values reported refer to ''adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses. | Posted | Mean | Standard Error | percentage of predicted | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1 (ppFEV1). Mean values reported refer to''difference vs placebo in adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses. | Posted | Mean | Standard Error | percentage of predicted | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in ppFEV1 (Subgroup ppFEV1 <90% at Baseline) | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''adjusted mean change from baseline'' values. | All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline.. | Posted | Mean | Standard Error | percentage of predicted | Day 15, Day 33, Day 54 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline) | Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values. | Subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline. | Posted | Mean | Standard Error | percentage of predicted | Day 15, Day 33, Day 54 |
|
For the SAD cohorts, from randomization up to Day 8 after dose administration. For the MAD cohorts, from randomization for at least 30 days after the last administration of the study treatment.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QR-010 SAD 6.25 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | QR-010 SAD 12.5 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | QR-010 SAD 25 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 9 | 0 | 9 | 7 | 9 |
| EG003 | QR-010 SAD 50 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline | 0 | 9 | 0 | 9 | 2 | 9 |
| EG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 0 | 6 | 5 | 6 |
| EG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 7 | 0 | 7 | 6 | 7 |
| EG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton | 0 | 6 | 1 | 6 | 5 | 6 |
| EG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline | 0 | 9 | 1 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment | General disorders and administration site conditions |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment | General disorders and administration site conditions |
|
Investigators are restricted from disclosure or results until after multicenter publication or 12 months after the completion of the Study at all participating research centers. Sponsor can review results communication prior to public release and can embargo communications regarding trial results for a period that is more than 45 days (varying per site). Sponsor may request redaction of confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | ProQR Therapeutics | +31 6 20 183 437 | clinical@proqr.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2017 | Oct 22, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708084 | eluforsen |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| United States |
|
| Czechia |
|
| Denmark |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| OG002 | QR-010 SAD 25 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG003 | QR-010 SAD 50 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| QR-010 SAD 50 mg |
QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG003 |
| QR-010 SAD 50 mg |
QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
| OG003 | QR-010 SAD 50 mg | QR-010 administered via inhalation as a single dose QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
| OG004 | Placebo SAD | Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline |
| OG005 | QR-010 MAD 6.25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG006 | QR-010 MAD 12.5 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG007 | QR-010 MAD 25 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG008 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG009 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
QR-010 administered via inhalation three times weekly for four weeks.
QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton
| OG003 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG003 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
|
|
|
QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG003 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
QR-010 administered via inhalation three times weekly for four weeks.
QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton
| OG003 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
|
|
|
| QR-010 MAD 50 mg |
QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| QR-010 MAD 50 mg |
QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
|
|
|
| OG003 |
| QR-010 MAD 50 mg |
QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
| OG004 | Placebo MAD | Placebo (normal saline) administered via inhalation three times weekly for four weeks. Placebo: Normal Saline |
|
|
| OG003 | QR-010 MAD 50 mg | QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton |
|
|
|
|
|
|
|