A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing

NCT05127772 | Completed Phase 1

• 1 other identifier: HEC93077-HUA-101
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.

Conditions

Gout

Outcome Measures

Primary Outcomes (10)

• the Number of Adverse Events (AEs)

  To investigate the safety and tolerability by assement of AEs following administration of oral solution in SAD and MAD

  up to 25 days

• PK parameters - AUC0-∞

  Area Under the Curve(AUC)

  up to 18 days

• PK parameters - Cmax

  Geometric Mean of Maximum Observed Plasma Concentration of HEC93077

  up to 18 days

• PK parameters -tmax

  maximum observed plasma concentration

  up to 18 days

• PK parameters -t½

  apparent terminal elimination half-life

  up to 18 days

• PK parameters -Vz/F

  apparent volume of distribution

  up to 18 days

• PD parameters

  Percentage of serum uric acid changed from baseline

  up to 18 days

• PK parameters - Ae0-t(urine)

  The amount of drug excreted in the urine

  up to 18 days

• PK parameters - Ae0-t(feces)

  The amount of drug excreted in the feces

  up to 18 days

• PK parameters-The cumulative rate of excretion

  The cumulative rate of durg excreted through urine/feces

  up to 18 days

Study Arms (12)

single dose of HEC93077（pilot trial arm）

EXPERIMENTAL

Healthy subjects receive single dose of HEC93077

Drug: HEC93077

single dose of HEC93077（Cohort 1）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

single dose of HEC93077（Cohort 2）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

single dose of HEC93077（Cohort 3,Fed/Fasting）

EXPERIMENTAL

Following an overnight fast of at least 10 hours, a single dose of HEC93077 or placebo will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.

single dose of HEC93077（Cohort 4）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

single dose of HEC93077（Cohort 5）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

single dose of HEC93077（Cohort 6）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

single dose of HEC93077（Cohort 7）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

multiple doses of HEC93077（ Cohort 8）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

multiple doses of HEC93077（ Cohort 9, Group 1)

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

multiple doses of HEC93077（ Cohort 9, Gruop 2)

EXPERIMENTAL

Hyperuricemia subjects receive multiple doses of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

multiple doses of HEC93077（ Cohort 10)

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC93077 or matching placebo

Drug: HEC93077; Drug: Placebo

Interventions

HEC93077 DRUG

Paticipants recieve HEC93077 orally single or Mulltiple doses up to 14 days

multiple doses of HEC93077（ Cohort 10); multiple doses of HEC93077（ Cohort 8）; multiple doses of HEC93077（ Cohort 9, Group 1); multiple doses of HEC93077（ Cohort 9, Gruop 2); single dose of HEC93077（Cohort 5）; single dose of HEC93077（Cohort 7）; single dose of HEC93077（pilot trial arm）

Placebo DRUG

Paticipants recieve placebo matching HEC93077 orally single or Mulltiple doses up to 14 days

multiple doses of HEC93077（ Cohort 10); multiple doses of HEC93077（ Cohort 8）; multiple doses of HEC93077（ Cohort 9, Group 1); multiple doses of HEC93077（ Cohort 9, Gruop 2); single dose of HEC93077（Cohort 5）; single dose of HEC93077（Cohort 7）

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Subjects aged between 18 and 45 (both inclusive) years old.
• Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
• Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
• Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• Serum uric acid≥240 and\<420 at screening.
• GFR≥90 mL/min/1.73 m2 at screening.

You may not qualify if:

• At screening subjects have the following diseases of clinical significance, including but not limited to cardiovascular system diseases, digestive system diseases, respiratory system diseases, urinary system diseases, endocrine and metabolic system diseases, blood system diseases, central nervous system and/or mental system diseases, immune system diseases, tumors, etc.
• A history of gastrointestinal, liver, or kidney disease or surgery prior to screening that could potentially affect the absorption, distribution, metabolism, and excretion of the test drug (except for uncomplicated appendectomy and hernia repair);
• History of urolithiasis or ultrasound screening showed urolithiasis, renal/ureteral malformation, unirenal or renal atrophy, polycystic kidney and other urological diseases
• History of gout and/or hyperuricemia
• Acute illness or concomitant use from signing the ICF to initial dosing.
• Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.(Allergic to more than 3 foods and/or medications)
• History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test at screening.
• History of drug abuse, or use of drugs within 2 years prior to the study,or positive results from urine drug screen test at screening.
• Regular smoking of more than 10 cigarettes per day within 3 months before screening period, or inability to refrain from smoking during the course of the study after signing ICF.
• Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
• Use of any prescription or non-prescription medications、vitamin and traditional Chinese medicine within 2 weeks prior to initial dosing,or use of any mediciations which affect UA synthesize,metabolize and excrete within 4 weeks prior to initial dosing.
• Use of any medications known to strongly inhibit and/or induce cytochrome P enzyme drug metabolism within 4 weeks prior to initial dosing.
• Have taken any food or drink that affects CYP3A4 and/or CYP1A2 metabolic enzymes within 2 days prior to initial dosing,such as grapefruit or grapefruit drink.
• Have taken chocolate, any food or drink containing caffeine or rich in xanthine within 72 hours prior to initial dosing.
• Have taken any alcoholic product within 48 hours prior to initial dosing.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Peking Universicity Care of Luzhong Hospital

Zibo, Shandong, 255400, China

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

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: November 9, 2021
• First Posted: November 19, 2021
• Study Start: November 22, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 1, 2026

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)