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Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and incompletely reversible airflow limitation. It is usually caused by airway and / or alveolar abnormalities caused by obvious exposure to toxic particles or gases.COPD is currently the fourth leading cause of death in the world, and is expected to be the third leading cause of death by 2020.HPP737 as an oral PDE4 inhibitor for the treatment of COPD.Preclinical data showed that the activity of HPP737 was similar to that of rofloxacin, but HPP737 significantly reduced the permeability to CNS and may have better tolerance. HPP737 will be used to develop indications for chronic obstructive pulmonary disease, and PK study in Chinese people is going to to evaluate the safety and tolerability of HPP737 in healthy volunteers.
This PK study it to evaluate the safety and tolerability of HPP737 in healthy subjects.
84 healthy subjects were included.A single dose of about 48 patients: expected 6mg, 10mg, 20mg, 40mg or undetermined, 12 subjects in each group, the ratio of HPP737 to placebo was 3:1 (9 cases: 3 cases), 6mg and 10mg could be carried out simultaneously.The dose group and the total number of subjects can be adjusted according to the latest data obtained.
There were 36 patients with multiple doses: expected 10mg, 20mg, 40mg or undetermined, with 12 subjects in each group. The ratio of HPP737 to placebo was 3:1 (9 cases: 3 cases). The dose group and total number of subjects could be adjusted according to the latest data. Multiple dose group and single dose group can be carried out simultaneously. Each multiple dose group will be enrolled after the first subject in the same dose group of single dose is enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD: Each volunteer will receive 6 mg, 10mg, 20mg, 40mg(or TBD) of IP once daily for 1 day | Experimental | Drug: HPP737 or placebo One 1 mg capsule and one 5mg capsule taken orally (by mouth) once daily for SAD arm 1/ Two 5mg capsule taken orally (by mouth) once daily for SAD arm 2/ Four 5mg capsule taken orally (by mouth) once daily for SAD arm 3/ Eight 5mg capsule taken orally (by mouth) once daily for SAD arm 4 |
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| MAD: Each volunteer will receive 10mg, 20mg, 40mg(or TBD) of IP once daily for 7 days | Experimental | Drug: HPP737 or placebo Two 5mg capsule taken orally (by mouth) once daily for MAD arm 1/ Four 5mg capsule taken orally (by mouth) once daily for MAD arm 2/ Eight 5mg capsule taken orally (by mouth) once daily for MAD arm 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPP737 or placebo | Drug | HPP737 or placebo will be randomized to assign to subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes of Safety and tolerability from day 1 to day 7 (SAD) or day 14(MAD) | Incidence and severity of various adverse events, including physical examination, blood routine, blood biochemistry, urine flow sediment test, coagulation function, vital signs (pulse, respiration, blood pressure, body temperature), electrocardiogram, etc | SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day; |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes of Pharmacokinetics (PK) evaluation mainly Cmax from day 1 to day 7 (SAD) or day 14 (MAD) | Plasma HPP737 concentration and pharmacokinetic parameters:Cmax | SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day; |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes of Pharmacokinetics (PK) evaluation mainly AUC0-24 from day 1 to day 7 (SAD) or day 14 (MAD) | Plasma HPP737 concentration and pharmacokinetic parameters: AUC0-24 | SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day; |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Chen, MS | Contact | 862152906192 | hannah.chen@newsoara.com |
| Name | Affiliation | Role |
|---|---|---|
| Nengming Lin, Dr | Hangzhou, Zhejiang Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hangzhou First People's Hospital.Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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SAD: planned 48 arms. 12 subjects each arm (Active: placebo=3:1) MAD: planned 36 arms. 12 subjects each arm (Active: placebo=3:1)
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