Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers

January 14, 2021 updated by: Newsoara Biopharma Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Affiliated Hangzhou First People's Hospital.Zhejiang University School of Medicine
        • Contact:
          • Nengming Lin, Dr
        • Contact:
          • Fei Wang, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent and participated in the study voluntarily;
  2. Male and female aged 45 to 18 years old;
  3. 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;
  4. 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)];

Exclusion Criteria:

  1. Have specific allergic history or allergic constitution such as drugs, food, pollen, etc., or be allergic to PDE4 inhibitors or similar drugs;
  2. 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;
  3. Screening or baseline showing abnormal vital signs, physical examination, laboratory examination, electrocardiogram and other results with clinical significance;
  4. Patients with history of malignant tumor in the past 5 years;
  5. Abnormal chest X-ray or abdominal B-ultrasound with clinical significance;
  6. Patients with positive HBsAg, HCV antibody, HIV antibody or syphilis antibody;
  7. Having a history of drug dependence or drug abuse, or positive urine drug abuse screening;
  8. Smokers (5 or more cigarettes a day);
  9. 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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAD: Each volunteer will receive 6 mg, 10mg, 20mg, 40mg(or TBD) of IP once daily for 1 day
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
Drug: HPP737 or placebo
HPP737 or placebo will be randomized to assign to subjects
Experimental: MAD: Each volunteer will receive 10mg, 20mg, 40mg(or TBD) of IP once daily for 7 days
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
Drug: HPP737 or placebo
HPP737 or placebo will be randomized to assign to subjects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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;
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;

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate changes of Pharmacokinetics (PK) evaluation mainly AUC0-24 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;
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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newsoara Biopharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nengming Lin, Dr, Hangzhou, Zhejiang Province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPP737-PK-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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