Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing Tide Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
CPD704 Inhalation Suspension
DrugThis trial employs standard jet nebulizers (air-compression nebulizers) for oral inhalation administration。
CPD704 placebo
Other interventionThe placebo is administered via standard jet nebulizer (air-compression nebulizer) for oral inhalation
Treatment groups
90 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: SAD 0.5mgOther 1 intervention
Group B: SAD 1.5mgOther 2 interventions
Group C: SAD 3mgOther 2 interventions
Group D: SAD 6mgOther 2 interventions
Group E: SAD 9mgOther 2 interventions
Group F: SAD 12mgOther 2 interventions
Group G: MAD 1.5mgOther 2 interventions
Group H: MAD 3mgOther 2 interventions
Group I: MAD 6mgOther 2 interventions
Trial outcomes
Primary outcomes
1
Safety outcomes
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.
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 outcomes
1
Pharmacokinetic (PK) endpoints
Plasma concentrations of CPD704 following nebulization of CPD704 inhalation suspension
Time frame
During the period starting 60 minutes before initial drug administration through to 48hours after first dose2
Pharmacokinetic (PK) endpoints
Cmax of CPD704 following nebulized administration of CPD704 inhalation suspension
Time frame
During the period starting 60 minutes before initial drug administration through to 48hours after last dose3
Pharmacokinetic (PK) endpoints
Time to reach peak plasma concentration (Tmax) of CPD704 following nebulized administration of CPD704 inhalation suspension
Time frame
During the period starting 60 minutes before initial drug administration through to 48hours after last dose4
Pharmacokinetic (PK) endpoints
Area under the plasma concentration-time curve from time zero to time t (AUC0-t) of CPD704 following nebulized administration of CPD704 inhalation suspension
Time frame
During the period starting 60 minutes before initial drug administration through to 48hours after last doseOther outcomes
1
QTcF interval
Evaluation of QTcF interval prolongation potential following single-dose administration of CPD704 inhalation suspension in healthy adult volunteers
Time frame
From 60 minutes prior to first dose until 12 hours of first dose.2
Metabolites and excretion pathways
Preliminary investigation of CPD704 metabolites in humans and primary excretion pathways, including cumulative excretion rates of the parent drug and metabolites (if applicable) in urine and feces
Time frame
only applicable for SAD 3mg cohort, From 60 minutes prior to first dose until 48Hours of last dose.Sponsors and contacts
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Source ClinicalTrials.gov