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Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC1316 Dose 1 | Experimental | Subjects will be administered with SPARC1316 dose 1 |
|
| Placebo | Placebo Comparator | The subjects will receive placebo. |
|
| SPARC1316 Dose 2 | Experimental | Subjects will be administered with SPARC1316 dose 2 |
|
| SPARC1316 Dose 3 | Experimental | Subjects will be administered with SPARC1316 dose 3 |
|
| SPARC1316 Dose 4 | Experimental | Subjects will be administered with SPARC1316 dose 4 |
|
| SPARC1316 Dose 5 | Experimental | Subjects will be administered with SPARC1316 dose 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1316 Dose 1 | Drug | The subjects will receive SPARC1316. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients | Two (2) Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC study site | London | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | S0597 Dose 1 | Subjects will be administered with SPARC1316 dose 1 |
| FG001 | S0597 Dose 2 | Subjects will receive SPARC1316 dose 2 |
| FG002 | S0597 Dose 3 | Subjects will receive SPARC1316 dose 3 |
| FG003 | S0597 Dose 4 | Subjects will receive SPARC1316 dose 4 |
| FG004 | S0597 Dose 5 | Subjects will receive SPARC1316 dose 5 |
| FG005 | Placebo | Subjects will receive placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | S0597 Dose 1 | Subjects will be administered with S0597 S0597: The subjects will receive S0597. Placebo |
| BG001 | S0597 Dose 2 | The subjects will receive placebo. S0597: The subjects will receive S0597. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Number of Subjects With Adverse Events | The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients | Posted | Number | participants | Two (2) Weeks |
|
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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 | S0597 Dose 1 | Subjects will be administered with S0597 S0597: The subjects will receive S0597. Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| URTI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shravanti Bhowmik | SPARC | +91 22 66455645 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo |
| Drug |
|
|
| SPARC1316 Dose 2 | Drug |
|
| SPARC1316 Dose 3 | Drug |
|
| SPARC1316 Dose 4 | Drug |
|
| SPARC1316 Dose 5 | Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | S0597 Dose 3 |
| BG003 | S0597 Dose 4 |
| BG004 | S0597 Dose 5 |
| BG005 | Placebo |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG004 | S0597 Dose 5 |
| OG005 | Placebo |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | S0597 Dose 2 | The subjects will receive placebo. S0597: The subjects will receive S0597. Placebo | 0 | 6 | 0 | 6 |
| EG002 | S0597 Dose 3 | 0 | 6 | 0 | 6 |
| EG003 | S0597 Dose 4 | 0 | 6 | 0 | 6 |
| EG004 | S0597 Dose 5 | 0 | 6 | 1 | 6 |
| EG005 | Placebo | 0 | 10 | 2 | 10 |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |