GoutPhase 1NCT05127772
A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing
A Phase 1 study testing HEC93077 in people with Gout, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- HEC93077
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2021to 31 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- GFR≥90 mL/min/1.73 m2 at screening.
- Patients who are willing and are able to provide a written informed consent to participate in the study.
- Patients aged between 18 and 60 (both inclusive) years old.
- Patients has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤30 kg/m2 at screening.
- During screening period, serum uric acid was ≥480 µmol/L twice on different days.Patients are considered to need to lower UA with a long term therapy;
- Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- GFR≥90 mL/min/1.73 m2 at screening.
Who cannot join
- 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)
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- 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.
- Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
- Subjects who plan to receive or have had organ transplants.
- Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- Subjects who canot tolerate fat food.(only suitable to FE trial)
- Subjects who maynot complete for other reasons.
- Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
- Hyperuricemia Patients：
- Patients with myocardial infarction, angina pectoris, percutaneous coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack within 6 months prior to screening.
- History of acute gout attack prior to initial dosing;
- Acute illness or use of a contraindicated drug under the protocol from signing the ICF to initial dosing.
- At screening,AST or ALT or TBIL >1.2 × ULN, or sCr >ULN，or HbA1c>8%.
- 4.Investigator judged the following conditons unsuitable for inclusion:Medical history, physical examination, electrocardiogram, chest X-ray, ultrasonic examination of digestive system , ultrasonic examination of urinary system and laboratory examination have abnormal and clinical significance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, PK, PDand Randomized, Open-label，Crossover, Food Effect Study of HEC93077 in Healthy Chinese Subjects and Hyperuricemia Patients
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
- Being tested
- HEC93077, Placebo
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC93077Drug
Paticipants recieve HEC93077 orally single or Mulltiple doses up to 14 days
PlaceboDrug
Paticipants recieve placebo matching HEC93077 orally single or Mulltiple doses up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| single dose of HEC93077（pilot trial arm） | Experimental | Healthy subjects receive single dose of HEC93077 Receives: 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 Receives: 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 Receives: Drug: HEC93077; Drug: Placebo |
| multiple doses of HEC93077（ Cohort 8） | Experimental | Healthy subjects receive multiple doses of HEC93077 or matching placebo Receives: Drug: HEC93077; Drug: Placebo |
| multiple doses of HEC93077（ Cohort 9, Group 1) | Experimental | Healthy subjects receive multiple doses of HEC93077 or matching placebo Receives: Drug: HEC93077; Drug: Placebo |
| multiple doses of HEC93077（ Cohort 9, Gruop 2) | Experimental | Hyperuricemia subjects receive multiple doses of HEC93077 or matching placebo Receives: Drug: HEC93077; Drug: Placebo |
| multiple doses of HEC93077（ Cohort 10) | Experimental | Healthy subjects receive multiple doses of HEC93077 or matching placebo Receives: Drug: HEC93077; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 25 days
PK parameters - AUC0-∞
Area Under the Curve(AUC)
Measured: up to 18 days
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC93077
Measured: up to 18 days
PK parameters -tmax
maximum observed plasma concentration
Measured: up to 18 days
PK parameters -t½
apparent terminal elimination half-life
Measured: up to 18 days
PK parameters -Vz/F
apparent volume of distribution
Measured: up to 18 days
PD parameters
Percentage of serum uric acid changed from baseline
Measured: up to 18 days
PK parameters - Ae0-t(urine)
The amount of drug excreted in the urine
Measured: up to 18 days
PK parameters - Ae0-t(feces)
The amount of drug excreted in the feces
Measured: up to 18 days
PK parameters-The cumulative rate of excretion
The cumulative rate of durg excreted through urine/feces
Measured: up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start22 Nov 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127772
- Sponsor's protocol ID
- HEC93077-HUA-101
- Status last verified
- Apr 2023
- First submitted
- 9 Nov 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, PK, PDand Randomized, Open-label，Crossover, Food Effect Study of HEC93077 in Healthy Chinese Subjects and Hyperuricemia Patients
- ClinicalTrials.gov ID
- NCT05127772
- Acronym / sponsor ID
- HEC93077-HUA-101
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| single dose of HEC93077（pilot trial arm） | Experimental | Drug: HEC93077Healthy subjects receive single dose of 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 | Drug: HEC93077, Drug: PlaceboHealthy subjects receive sinele dose of HEC93077 or matching 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 | Drug: HEC93077, Drug: PlaceboHealthy subjects receive sinele dose of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 8） | Experimental | Drug: HEC93077, Drug: PlaceboHealthy subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 9, Group 1) | Experimental | Drug: HEC93077, Drug: PlaceboHealthy subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 9, Gruop 2) | Experimental | Drug: HEC93077, Drug: PlaceboHyperuricemia subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 10) | Experimental | Drug: HEC93077, Drug: PlaceboHealthy subjects receive multiple doses of HEC93077 or matching placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC93077Paticipants recieve HEC93077 orally single or Mulltiple doses up to 14 days | Drug | 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） |
| PlaceboPaticipants recieve placebo matching HEC93077 orally single or Mulltiple doses up to 14 days | Drug | 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） |
Primary outcome
the Number of Adverse Events (AEs)
Time frame: up to 25 days
To investigate the safety and tolerability by assement of AEs following administration of oral solution in SAD and MAD
PK parameters - AUC0-∞
Time frame: up to 18 days
Area Under the Curve(AUC)
PK parameters - Cmax
Time frame: up to 18 days
Geometric Mean of Maximum Observed Plasma Concentration of HEC93077
PK parameters -tmax
Time frame: up to 18 days
maximum observed plasma concentration
PK parameters -t½
Time frame: up to 18 days
apparent terminal elimination half-life
PK parameters -Vz/F
Time frame: up to 18 days
apparent volume of distribution
PD parameters
Time frame: up to 18 days
Percentage of serum uric acid changed from baseline
PK parameters - Ae0-t(urine)
Time frame: up to 18 days
The amount of drug excreted in the urine
PK parameters - Ae0-t(feces)
Time frame: up to 18 days
The amount of drug excreted in the feces
PK parameters-The cumulative rate of excretion
Time frame: up to 18 days
The cumulative rate of durg excreted through urine/feces
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC93077 in people with Gout, run by Sunshine Lake Pharma 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 13 inclusion and 28 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: finished, as of the sponsor's last update on 1 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Number of Adverse Events (AEs) (time frame: up to 25 days). The study lists 10 primary outcomes in all. 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 1 May 2026.