A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects

NCT06858657 | Completed Phase 1

• 1 other identifier: HSK44459-101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK44459 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.

Conditions

Healthy

Keywords

HSK44459; healthy subjects; phase1

Outcome Measures

Primary Outcomes (1)

• The number and severity of treatment emergent adverse events (TEAEs)

  To assess the safety and tolerability of single or multiple oral dose of HSK44459 in healthy adult volunteers

  7 days after single dose and 3 days after the first dose of multiple doses

Study Arms (2)

HSK4449

EXPERIMENTAL

Single or multiple oral doses of HSK44459, and food effect of HSK44459

Drug: HSK44459

Placebo

PLACEBO COMPARATOR

Single or multiple oral doses of placebo, and food effect of placebo

Drug: placebo

Interventions

HSK44459 DRUG

Dose 1 to Dose 5

HSK4449

placebo DRUG

dose 1 to dose 5

Placebo

Eligibility Criteria

• Age: 18 Years - 55 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 55 years (inclusive), male and female;
• Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 19-26 kg/m2 (inclusive) ;
• 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 an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
• Have a history of any malignant tumors;
• The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;
• Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;
• Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
• Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;
• 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, or positive urine drug screen at screening;
• Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice;
• Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
• Subjects who have a allergic to any component of HSK44459 or allergic history to opiates;
• 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)

Nanjing Drum Tower Hospital

Nanjing, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: March 5, 2025
• Study Start: August 17, 2024
• Primary Completion: November 18, 2024
• Study Completion: December 20, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)