Asthma
Conditions
Keywords
pharmacokinetics, pharmacodynamics, asthma
Brief summary
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.
Interventions
DRUGSPARC1316 Dose 1
The subjects will receive SPARC1316.
DRUGPlacebo
DRUGSPARC1316 Dose 2
DRUGSPARC1316 Dose 3
DRUGSPARC1316 Dose 4
DRUGSPARC1316 Dose 5
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects willing to provide informed consent * Male or female subjects aged 18 to 65 years inclusive * Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive * Non-smokers or ex-smokers
Exclusion criteria
* Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg * Subjects who have a significant infection or known inflammatory process on screening or admission. * Subjects who are unlikely to co-operate with the requirements of the study. * Positive serology for infectious disease (hepatitisB or C , HIV) at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events | Two (2) Weeks | The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S0597 Dose 1 Subjects will be administered with S0597
S0597: The subjects will receive S0597.
Placebo | 6 |
| S0597 Dose 2 The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo | 6 |
| S0597 Dose 3 | 6 |
| S0597 Dose 4 | 6 |
| S0597 Dose 5 | 6 |
| Placebo | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | S0597 Dose 1 | S0597 Dose 2 | S0597 Dose 3 | S0597 Dose 4 | S0597 Dose 5 | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized | 33 years STANDARD_DEVIATION 3.9 | 28 years STANDARD_DEVIATION 8.2 | 28 years STANDARD_DEVIATION 4.9 | 27 years STANDARD_DEVIATION 8.8 | 31 years STANDARD_DEVIATION 5.8 | 27 years STANDARD_DEVIATION 5.3 | 29 years STANDARD_DEVIATION 6.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 10 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 2 / 10 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 |
Outcome results
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
Time frame: Two (2) Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S0597 Dose 1 | Number of Subjects With Adverse Events | 0 participants |
| S0597 Dose 2 | Number of Subjects With Adverse Events | 0 participants |
| S0597 Dose 3 | Number of Subjects With Adverse Events | 0 participants |
| S0597 Dose 4 | Number of Subjects With Adverse Events | 0 participants |
| S0597 Dose 5 | Number of Subjects With Adverse Events | 1 participants |
| Placebo | Number of Subjects With Adverse Events | 2 participants |