Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects

Official title

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Doses of CPD704 Inhalation Suspension in Healthy Chinese Adult Subjects.

Overview

This is a Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of CPD704 inhalation suspension in healthy Chinese adult subjects.

Detailed description

This study is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of CPD704 inhalation suspension administered via nebulization in healthy Chinese adult subjects.

Interventions

• Drug CPD704 Inhalation Suspension
  This trial employs standard jet nebulizers (air-compression nebulizers) for oral inhalation administration。
• Other CPD704 placebo
  The placebo is administered via standard jet nebulizer (air-compression nebulizer) for oral inhalation

Primary outcome measures

• Safety outcomes [Time frame: From the date of informed consent signature until Day 7 for SAD group(Day 14 for SAD 3mg group) and Day 11 for MAD Group.]

Secondary outcome measures (6)

• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after first dose]
• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after last dose]
• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after last dose]
• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after last dose]
• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after last dose]
• Pharmacokinetic (PK) endpoints [Time frame: During the period starting 60 minutes before initial drug administration through to 48hours after last dose]

Eligibility criteria

Inclusion criteria

• The subject can communicate well with the researchers, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form;
• Healthy subjects aged 18-55 years (including the boundary value, subject to the time of signing the informed consent form), male or female;
• Body mass index (BMI) within the range of 19 \~ 28 kg/m2 (including the critical value), male weight ≥ 50 kg, female weight ≥ 45 kg;
• The subject has no plans to give birth, sperm or egg donation from the signing of the informed consent form to 90 days after medication, and voluntarily takes medically approved contraceptive measures (including his partner)

Exclusion criteria

• Patients who have taken any clinical trial drugs or participated in any drug clinical trial within 3 months before signing the ICF, or participated in other medical research activities, and are not suitable for participating in this trial as judged by the investigator;
• Previous or combined with the following diseases, cardiovascular disease \[such as heart failure (such as fluid retention and edema), unstable ischemic heart disease, congestive heart failure poor control of coronary artery disease, myocardial infarction, long QT syndrome history, etc.\], respiratory, renal, neurological, endocrine, immune, skin, gastrointestinal (such as gastrointestinal ulcers or gastrointestinal bleeding, etc.), liver or blood system and other diseases/abnormal history, the investigators judge that their participation in this trial may affect the safety of subjects or affect the analysis of study results;
• Patients with the following mental illness: 1) Uncontrolled/unstable major depressive disorder (MDD) or other serious mental disorders (such as schizophrenia, bipolar disorder or other serious mood or anxiety disorders) within 2 years before screening; 2) Suicide attempt or suicidal behavior 30 times before screening; 3) Suicidal ideation corresponding to Columbia-Suicide Severity Rating Scale (C-SSRS) category 4 or 5 in the past 30;
• Known hypersensitivity, immune reaction or intolerance to CPD704 Inhalation Suspension or any of the excipients in the drug product (polysorbate 80, sodium chloride, sodium citrate dihydrate, disodium edetate, sodium hydroxide or hydrochloric acid) and/or unsuitable for treatment with CPD704 Inhalation Suspension;
• Long-term oral drugs can not be stopped or suffering from gastric ulcer, gastritis affecting oral activated charcoal, or allergic to activated charcoal;
• Patients with severe infection, trauma or major surgery before signing the ICF, or planning to undergo surgery during the trial;
• Use of any live vaccines (except influenza vaccine) within 28 days before signing the ICF or plan to receive vaccines during the study;
• Blood loss or blood donation of more than 400 mL within 3 months before signing the ICF (excluding female menstrual blood loss), or intend to donate blood during the trial or within 1 month after the end of the trial;
• Smokers or those who smoke more than 5 cigarettes per day within 3 months before signing the ICF, or those who cannot comply with the provisions of prohibiting smoking during the trial, or those who test positive for urine cotinine;
• Pulmonary ventilation function test Forced expiratory volume in the first second (FEV1) measured value/FEV1 predicted value ≤ 80% or forced vital capacity (FVC) ≤ 80% of predicted value or any other clinically significant abnormalities;
• Use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 28 days before signing the ICF; or use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before signing the ICF. If the half-life of concomitant drugs is increased, the required time interval should be at least 5 half-lives of the drug;
• Excessive consumption of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, 250 mL per cup) within 6 months before signing the ICF;
• Consumption of any grapefruit, caffeine-containing beverages or foods (such as grapefruit juice, coffee, strong tea, chocolate, caffeine-containing carbonated beverages, cola, cocoa, etc.) within 48 hours before the first dose;
• Those who have special requirements for diet and cannot abide by the unified diet;
• Unwilling or unable to tolerate multiple venipuncture or difficult venous blood sampling or a history of fainting;
• Previous history of drug abuse/drug use, or drug abuse screening (including tetrahydrocannabinolic acid, morphine, ketamine, methamphetamine, benzodiazepine, cocaine) results were positive;
• Regular drinking within 6 months before signing the ICF \[i.e., women drink more than 14 standard units of alcohol per week, men drink more than 21 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine)\] or can not abstain from alcohol during the trial; or positive breath alcohol test;
• The results of physical examination, vital signs examination, ECG, laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function, urine routine, stool routine, etc.), chest X-ray, abdominal B ultrasound examination during the screening period are judged by the study doctor as abnormal and clinically significant;
• Abnormal ECG findings during the screening period, such as bradycardia or tachycardia (heart rate < 50 bpm or > 100 bpm), QTc prolongation (QTcF interval ≥ 450 ms in males and ≥ 470 ms in females, corrected according to Fridericia's formula), arrhythmia, etc., and clinically significant as judged by the investigator;
• Patients with positive results of any test of hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (Syphilis TP) and human immunodeficiency virus test (HIV-Ag/Ab) during the screening period;
• Pregnant or lactating women, or positive blood pregnancy test results;
• Unwilling or unable to correctly use the nebulizer according to the nebulizer instructions Inhalation of investigational drugs or nebulizer use training failed;
• Any other condition that, in the opinion of the investigator, would make participation in the study inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07301203 · CPX201-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗