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

NCT04714294 | Unknown Phase 1

• 1 other identifier: HPP737-PK-103
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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;

Secondary Outcomes (1)

• Evaluate changes of Pharmacokinetics (PK) evaluation mainly Cmax from day 1 to day 7 (SAD) or day 14 (MAD)

  SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;

Other Outcomes (1)

• Evaluate changes of Pharmacokinetics (PK) evaluation mainly AUC0-24 from day 1 to day 7 (SAD) or day 14 (MAD)

  SAD: from the screening period to the 7th day; MAD: from the screening period to the 14th day;

Study Arms (2)

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

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

Drug: HPP737 or placebo

Interventions

HPP737 or placebo DRUG

HPP737 or placebo will be randomized to assign to subjects

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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), \[BMI = weight (kg)) height2(M2)\];

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (1)

Affiliated Hangzhou First People's Hospital.Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

Study Officials

• Nengming Lin, Dr

  Hangzhou, Zhejiang Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Chen, MS

CONTACT

862152906192; hannah.chen@newsoara.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD: planned 48 arms. 12 subjects each arm (Active: placebo=3:1) MAD: planned 36 arms. 12 subjects each arm (Active: placebo=3:1)

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 19, 2021
• Study Start: September 8, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 19, 2021

Record last verified: 2020-12

Locations

CN (1)