Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of HSK39004 Suspension for Inhalation

NCT06905847 | Completed Phase 1

• 1 other identifier: HSK39004-101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）.

Conditions

Healthy Donors

Outcome Measures

Primary Outcomes (1)

• adverse events

  The Incidence of adverse events as assessed by CTCAE v5.0

  From the enrollment of the subjects to 72 hours after the last administration

Secondary Outcomes (6)

• AUC

  from 0 to 72 hours after administration

• Cmax

  from 0 to 72 hours after administration

• t1/2

  from 0 to 72 hours after administration

• Vz/F

  from 0 to 72 hours after administration

• CL/F

  from 0 to 72 hours after administration

Study Arms (3)

HSK39004 in healthy volenteers

EXPERIMENTAL

Single or multiple inhaled HSK39004

Drug: HSK39004 in healthy

Placebo

PLACEBO COMPARATOR

Placebo

Drug: HSK39004

HSK39004 in COPD patients

EXPERIMENTAL

multiple inhaled HSK39004

Drug: HSK39004 in COPD

Interventions

HSK39004 in healthy DRUG

1.5-12mg

HSK39004 in healthy volenteers

HSK39004 DRUG

Placebo

Placebo

HSK39004 in COPD DRUG

1.5-6mg

HSK39004 in COPD patients

Eligibility Criteria

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

You may qualify if:

• For healthy volenteers:
• Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
• years to 45 years (inclusive), male and female;
• Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ;
• Ability to perform acceptable and reproducible spirometry;
• Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
• Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
• For COPD patients:
• Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
• Age ≥ 40 years , male and female;
• According to the diagnostic criteria of 2024 Practical Edition of Guidelines , the patient was diagnosed with COPD; The patient has chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or a history of exposure to risk factors, and the results of pulmonary function tests show that post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 ;
• At screening: post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥40 % to ≤80% of predicted normal and FEV1 increased by ≥100ml compared with pre-bronchiectasis;
• No regular treatment of COPD was performed before joining the study. COPD agents (except SABA and/or SAMA) that are contraindicated in the protocol may be discontinued during the screening and treatment;
• Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

You may not qualify if:

• For healthy volenteers:
• Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
• Have a history of any malignant tumors;
• Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance (only for healthy subjects);
• Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
• Acute respiratory infections occurred within 6 weeks before screening and/or before randomization;
• Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
• Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study (only for healthy subjects);
• Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;
• Have a history of drug abuse prior to screening, or positive urine drug screen at screening (If COPD patients were false positives due to other medications, they can be retested after the medication is washed);
• Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening;
• Subjects who have a allergic to any component of HSK39004 or allergic history to opiates;
• Intolerance to this product or the same target drug;
• Subjects who use any live vaccine within 30 days prior to screening;
• Have participated in any clinical investigator within 3 months prior to screening;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

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: December 31, 2024
• First Posted: April 2, 2025
• Study Start: September 2, 2024
• Primary Completion: January 13, 2025
• Study Completion: March 20, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-12

Locations

CN (1)