Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder Inhalation

NCT06971198 | Completed Phase 1

• 1 other identifier: HSK39004-T1-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 dry powder inhalation in healthy subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• adverse events

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

Secondary Outcomes (5)

• 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 (2)

HSK39004

EXPERIMENTAL

Drug: HSK39004

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

HSK39004 DRUG

0.75\~4mg

HSK39004

Placebo DRUG

0.75\~4mg

Placebo

Eligibility Criteria

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

You may qualify if:

• 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) ;
• Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
• Never smoked or have quit smoking for ≥ 12 months and have a previous smoking history of \< 5 pack per years;
• Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

You may not qualify if:

• 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;
• 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 within 48 hours before the administration;
• 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;
• 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;
• Subjects who use any live vaccine within 30 days prior to screening;
• Have participated in any clinical investigator within 3 months prior to screening;
• A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
• Not suitable for this study as judged by the investigator.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: February 10, 2025
• Primary Completion: March 28, 2025
• Study Completion: May 6, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)