Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects

NCT05851261 | Completed Phase 1

• 1 other identifier: PA3670-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are to evaluate the safety and tolerance of single and multiple oral administration of PA3670 tablets in Chinese adult healthy subjects and the effect of food on pharmacokinetics of PA3670 tablets in Chinese adult healthy subjects.

Conditions

Chronic HBV Infection

Outcome Measures

Primary Outcomes (12)

• Body temperature

  Vital sign-body temperature

  Up to 72 hours after last dose

• Systolic and diastolic blood pressure

  Vital sign-Systolic and diastolic blood pressure

  Up to 72 hours after last dose

• Pulse rate

  Vital sign-Pulse rate

  Up to 72 hours after last dose

• Breathing rate

  Vital sign-Breathing rate

  Up to 72 hours after last dose

• Number of subjects having abnormal hematology laboratory parameters

  Absolute and relative number of subjects with values below, within or above the normal range will be assessed.

  Up to 72 hours after last dose

• Number of subjects with abnormal clinical chemistry parameters

  Absolute and relative number of subjects with values below, within or above the normal range will be assessed.

  Up to 72 hours after last dose

• Number of subjects with abnormal values for urinalysis

  Absolute and relative number of subjects with values below, within or above the normal range will be assessed.

  Up to 72 hours after last dose

• Number of subjects with abnormal with blood coagulation function

  Absolute and relative number of subjects with values below, within or above the normal range will be assessed.

  Up to 72 hours after last dose

• ECG parameter-QTc interval

  A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval

  Up to 72 hours after last dose

• ECG parameter-PR interval

  A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR interval.

  Up to 72 hours after last dose

• ECG parameter-QRS duration

  A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration

  Up to 72 hours after last dose

• Number of subjects experiencing adverse events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.

  7 days or 15 days

Secondary Outcomes (3)

• Pharmacokinetics of PA3670-Cmax

  4 days or 12 days

• Pharmacokinetics of PA3670-Tmax

  4 days or 12 days

• Pharmacokinetics of single dose of PA3670-AUC

  4 days or 12 days

Study Arms (6)

PA3670 5 mg

PLACEBO COMPARATOR

Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.

Drug: PA3670

PA3670 15 mg

PLACEBO COMPARATOR

Ten subjects will be randomly assigned in a ratio of 4:1 to receive 15 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.

Drug: PA3670

PA3670 30 mg

PLACEBO COMPARATOR

Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.

Drug: PA3670

PA3670 15 mg for 9days

PLACEBO COMPARATOR

Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 15mg of PA3670 tablets or PA3670 placebo tablets, once daily for 9 days.

Drug: PA3670

PA3670 15mg before and after meals

OTHER

Ten subjects will be administered 15mg PA3670 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA3670 within 30 minutes after high-fat meal in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days.

Drug: PA3670

PA3670 15mg after and before meals

OTHER

Ten subjects will be administered 15mg PA3670 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA3670 after overnight fasting 10 hours in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days.

Drug: PA3670

Interventions

PA3670 DRUG

Placebo as control

PA3670 15 mg; PA3670 15 mg for 9days; PA3670 15mg after and before meals; PA3670 15mg before and after meals; PA3670 30 mg; PA3670 5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy male and female subjects aged from 18 to 65 (inclusive);
• \. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) between 19 and 28 kg/m2 (including the critical value);
• \. Be able to complete the test according to the study protocol;
• \. Voluntary participation and signing of informed consent.

You may not qualify if:

• \. There are any medical conditions that the investigator thinks may increase the risk of the subject participating in the study (especially the history of esophageal or gastrointestinal ulcer), may interfere with drug absorption, distribution, metabolism or excretion, or may weaken the compliance of the study protocol;
• \. Allergic to the study drug or any component of the study drug, or allergic (refers to allergic to 2 or more kinds of food, drugs or environmental substances);
• \. The vital signs, physical examination, laboratory examination (blood routine test, blood biochemistry, urine routine test, blood coagulation function, etc.), chest X-ray examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), 12 lead ECG, etc. in the screening period were judged abnormal and had clinical significance;
• \. Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody and HIV antibody;
• \. Those who regularly drank alcohol within 3 months before screening, i.e., those who drank more than 14 units of alcohol every week (1 unit=360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), or those who had positive alcohol breath test in the baseline period or could not stop drinking alcohol during the study period;
• \. Those who smoke ≥ 5 cigarettes a day within 3 months before screening, those who are positive for nicotine test in the baseline period, or those who cannot stop using any tobacco products during the test period;
• \. Those who have a history of drug abuse and drug abuse in the past two years, or who are positive for urine screening of drug abuse at baseline (including morphine, methamphetamine, ketamine, benzodiazepine, cocaine, tetrahydrocannabinol acid);
• \. Those who have used any drugs (prescription drugs, over-the-counter drugs, Chinese herbal medicine, vaccines) or health products within 4 weeks before screening and during screening;
• \. Those who take any food or drink rich in caffeine and xanthine (coffee, tea, cola, chocolate, seafood, animal liver, etc.) within 48 hours before the first use of the study drug, or do not agree to stop eating the above diet during the test period;
• \. Female subjects had unprotected sex in the past two weeks; Male subjects (or their partners) or female subjects who have fertility plans or donated sperm and eggs during the whole test period and within 3 months after administration, and who are unwilling to take one or more physical contraceptive measures or are breastfeeding during the test period;
• \. Those who donate blood or lose a lot of blood (≥ 200 mL, except female physiological period) or use blood products or transfusions within 90 days before screening and during screening;
• \. Those who participated in other clinical study within 90 days before screening or who participated in other clinical trials for less than 7 days;
• \. Those who have undergone major surgery within 6 months before screening (judged by the researcher based on previous medical history data), suffered major trauma or planned to undergo surgery during the study period;
• \. Difficulty in venous blood collection, or known history of needle and blood fainting;
• \. Positive blood pregnancy test during screening period;

Sponsors & Collaborators

• Zhejiang Palo Alto Pharmaceuticals, Inc.: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Study Officials

• Hong Ren, MD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 9, 2023
• Study Start: April 13, 2023
• Primary Completion: October 24, 2023
• Study Completion: December 19, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)