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HealthyPhase 1NCT07301203

Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects

A Phase 1 study testing CPD704 Inhalation Suspension in people with Healthy and Healthy Participants, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Healthy Participants
What is being tested?
CPD704 Inhalation Suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
21 Oct 2025to 18 Jul 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100020

    Jintong Li, +8615300059186, gcpljt@189.cn

    Recruiting

Other trials in China

About this study

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.

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.

Read the 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.

Being tested
CPD704 Inhalation Suspension, CPD704 placebo
Keywords
Phase I Study of CPD704 in Healthy Subjects, CPX201-I-01

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPD704 Inhalation SuspensionDrug

    This trial employs standard jet nebulizers (air-compression nebulizers) for oral inhalation administration。

  • CPD704 placeboOther

    The placebo is administered via standard jet nebulizer (air-compression nebulizer) for oral inhalation

Study groups in NCT07301203
Study groupRoleWhat they receive
SAD 0.5mgOtherFor SAD 0.5mg cohort will enroll 2 subjects who will receive CPD704 once. 0.5 mg per administration
Receives: Drug: CPD704 Inhalation Suspension
SAD 1.5mgOtherThe SAD 1.5mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant.1.5 mg per administration.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
SAD 3mgOtherThis group will include exploratory studies onmetabolite identification, excretion pathways, and excretion quantification(conducted in Cycle 1) as well as anactivated charcoal gastrointestinal absorption blockade study(conducted in Cycle 2). A total of12 subjects will be enrolled (10:2 =CPD704 treatment group: placebo group), Each subject will receive a single 3 mg dose per cycle via oral inhalation.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
SAD 6mgOtherThe SAD 6mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,6 mg per administration.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
SAD 9mgOtherThe SAD 9mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,9 mg per administration.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
SAD 12mgOtherThe SAD 12mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,12 mg per administration..
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
MAD 1.5mgOtherEach cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation. Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses).1.5 mg per administration.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
MAD 3mgOtherEach cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation. Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses) . 3 mg per administration.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo
MAD 6mgOtherEach cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation. Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses). Each dose:6mg.
Receives: Drug: CPD704 Inhalation Suspension; Other: CPD704 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety outcomes

    Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.

    Measured: 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 (6)
  1. Pharmacokinetic (PK) endpoints

    Plasma concentrations of CPD704 following nebulization of CPD704 inhalation suspension

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after first dose

  2. Pharmacokinetic (PK) endpoints

    Cmax of CPD704 following nebulized administration of CPD704 inhalation suspension

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after last dose

  3. Pharmacokinetic (PK) endpoints

    Time to reach peak plasma concentration (Tmax) of CPD704 following nebulized administration of CPD704 inhalation suspension

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after last dose

  4. 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

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after last dose

  5. Pharmacokinetic (PK) endpoints

    t1/2 of CPD704 after nebulization of CPD704 inhalation suspension

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after last dose

  6. Pharmacokinetic (PK) endpoints

    PK profile of CPD704 inhalation suspension following activated charcoal blockade (including AUC0-∞, AUC0-t, Cmax and other parameters)

    Measured: During the period starting 60 minutes before initial drug administration through to 48hours after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start21 Oct 2025
  3. Primary completion8 Jun 2026 (estimated)
  4. Study completion18 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07301203
Sponsor's protocol ID
CPX201-I-01
Status last verified
Sep 2025
First submitted
19 Nov 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPD704 Inhalation Suspension in people with Healthy and Healthy Participants, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanru Yanru (+8618210654987, yanru.yan@cplabpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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