HealthyPhase 1NCT04714294
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
A Phase 1 study of Healthy, run by Newsoara Biopharma Co., Ltd. at 1 site in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and incompletely reversible airflow limitation. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2020to 31 May 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent and participated in the study voluntarily;
- Male and female aged 45 to 18 years old;
- Male or female who agree to take effective contraception from the screening period to 90 days after the last medication of the trial, and agree to take at least one effective contraceptive measure;
- In the screening and baseline period, the body weight of male was no less than 50kg, and that of female was no less than 45kg. Body mass index (BMI) was in the range of 19-24kgm2(including 19 and 24), [BMI = weight (kg)) height2(M2)];
Who cannot join
- Have specific allergic history or allergic constitution such as drugs, food, pollen, etc., or be allergic to PDE4 inhibitors or similar drugs;
- Patients with previous diseases of neuropsychiatric system, respiratory system, cardiovascular system, digestive system, haemolymph system, liver and kidney system, endocrine system, skeletal muscle system or other diseases, and the investigator judged that the previous medical history may have an impact on drug metabolism or safety;
- Screening or baseline showing abnormal vital signs, physical examination, laboratory examination, electrocardiogram and other results with clinical significance;
- Patients with history of malignant tumor in the past 5 years;
- Abnormal chest X-ray or abdominal B-ultrasound with clinical significance;
- Patients with positive HBsAg, HCV antibody, HIV antibody or syphilis antibody;
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- Having a history of drug dependence or drug abuse, or positive urine drug abuse screening;
- Smokers (5 or more cigarettes a day);
- Alcoholics (drinking more than 14 units per week, each unit is equivalent to 360ml beer or 150ml wine or 45ml liquor with 40% alcohol volume);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hangzhou First People's Hospital.Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Nengming Lin, Dr
Fei Wang, MS
About this study
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- HPP737 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPP737 or placeboDrug
HPP737 or placebo will be randomized to assign to subjects
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HPP737 or placebo |
| 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 Receives: Drug: HPP737 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;
Secondary outcomes (1)
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
Measured: SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 Sep 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Model description
- SAD: planned 48 arms. 12 subjects each arm (Active: placebo=3:1) MAD: planned 36 arms. 12 subjects each arm (Active: placebo=3:1)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newsoara Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nengming Lin, Dr, Principal investigator, Hangzhou, Zhejiang Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714294
- Sponsor's protocol ID
- HPP737-PK-103
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT04714294
- Acronym / sponsor ID
- HPP737-PK-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Newsoara Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 19 Jan 2021 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SAD: planned 48 arms. 12 subjects each arm (Active: placebo=3:1) MAD: planned 36 arms. 12 subjects each arm (Active: placebo=3:1)
| Arm | Type | Receives |
|---|---|---|
| SAD: Each volunteer will receive 6 mg, 10mg, 20mg, 40mg(or TBD) of IP once daily for 1 day | Experimental | Drug: HPP737 or placeboDrug: 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 |
| MAD: Each volunteer will receive 10mg, 20mg, 40mg(or TBD) of IP once daily for 7 days | Experimental | Drug: HPP737 or placeboDrug: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent and participated in the study voluntarily;
- Male and female aged 45 to 18 years old;
- Male or female who agree to take effective contraception from the screening period to 90 days after the last medication of the trial, and agree to take at least one effective contraceptive measure;
- In the screening and baseline period, the body weight of male was no less than 50kg, and that of female was no less than 45kg. Body mass index (BMI) was in the range of 19-24kgm2(including 19 and 24), [BMI = weight (kg)) height2(M2)];
Key exclusion criteria (9 listed)
- Have specific allergic history or allergic constitution such as drugs, food, pollen, etc., or be allergic to PDE4 inhibitors or similar drugs;
- Patients with previous diseases of neuropsychiatric system, respiratory system, cardiovascular system, digestive system, haemolymph system, liver and kidney system, endocrine system, skeletal muscle system or other diseases, and the investigator judged that the previous medical history may have an impact on drug metabolism or safety;
- Screening or baseline showing abnormal vital signs, physical examination, laboratory examination, electrocardiogram and other results with clinical significance;
- Patients with history of malignant tumor in the past 5 years;
- Abnormal chest X-ray or abdominal B-ultrasound with clinical significance;
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 |
|---|---|---|
| HPP737 or placeboHPP737 or placebo will be randomized to assign to subjects | Drug | MAD: Each volunteer will receive 10mg, 20mg, 40mg(or TBD) of IP once daily for 7 days, SAD: Each volunteer will receive 6 mg, 10mg, 20mg, 40mg(or TBD) of IP once daily for 1 day |
Primary outcome
Evaluate changes of Safety and tolerability from day 1 to day 7 (SAD) or day 14(MAD)
Time frame: SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;
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
1 secondary outcome
Evaluate changes of Pharmacokinetics (PK) evaluation mainly Cmax from day 1 to day 7 (SAD) or day 14 (MAD)
Time frame: SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Nengming Lin, Dr principal investigator
Hangzhou, Zhejiang Province
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 of Healthy, run by Newsoara Biopharma Co., Ltd. at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Chen, MS (862152906192, hannah.chen@newsoara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate changes of Safety and tolerability from day 1 to day 7 (SAD) or day 14(MAD) (time frame: SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;). 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 19 Jan 2021.