Healthy SubjectsPhase 1NCT06867393
Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects
A Phase 1 study testing HL-003 tablet Placeco and HL-003 tablet in people with Healthy Subjects, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
Trial summary
This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HL-003 tablet Placeco and HL-003 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender.
- Males must weigh ≥50 kg, and females must weigh ≥45 kg. The Body Mass Index (BMI) should be within the range of 19 to 26 kg/m² (including the threshold values).
- Serum creatinine levels must be within the normal range during the screening period, and the Creatinine Clearance (CCr) must be ≥90 mL/min (including the threshold value, calculated using the CKD-EPI formula.
- Comprehensive physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), and laboratory tests (including blood routine, blood biochemistry, thyroid function, parathyroid function, coagulation function, urinalysis, etc.) must all be within normal ranges or show no clinically significant abnormalities.
- Participants must agree not to plan for pregnancy during the trial and for 3 months after taking the medication, and must use reliable contraceptive methods.
- Participants must be able to communicate effectively with researchers, fully understand the purpose, methods, requirements, and potential adverse reactions of the trial, voluntarily participate in the clinical trial, sign a written informed consent form, and be able to complete the clinical trial according to the protocol requirements.
Who cannot join
- History of known allergy to the investigational drug or any of its components/related formulations; history of allergic reactions to two or more medications, foods, etc., or individuals with hypersensitive constitution;
- Subjects with special dietary requirements who cannot comply with standardized meals;
- History of frequent nausea or vomiting from any cause;
- QTcF interval >450 msec (calculation formula in Appendix 14-3);
- Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody;
- Consumption of caffeine-rich foods/beverages within 48h before dosing, or unwillingness to abstain during the study;
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- Any medical history/comorbidities that may affect safety assessment or drug metabolism, including CNS, cardiovascular, digestive, respiratory, urinary, hematologic, immunological, psychiatric disorders, metabolic abnormalities, or gastrointestinal surgery (except appendectomy);
- Blood loss ≥400 mL or blood transfusion within 3 months before dosing; Blood donation (including component donation) ≥200 mL within 1 month before dosing;
- Use of CYP3A4/CYP2C9/CYP2C8 inhibitors/inducers within 30 days before dosing; Any prescription/OTC medications/herbal products within 14 days before dosing;
- Participation in other drug trials within 3 months before dosing;
- Current/past drug addiction or positive drug abuse screening;
- Excessive alcohol consumption (>14 units/week; 1 unit=360mL beer/45mL 40% liquor/150mL wine) within 3 months or unwillingness to abstain during the study;
- Heavy smoking (>5 cigarettes/day within 3 months) or inability to abstain during the study;
- Consumption of CYP-affecting foods (grapefruit/pomelo/lime products) within 48h before dosing, or refusal to abstain during the study;
- Poor compliance or other investigator-determined unsuitable factors;
- Additional female exclusions:
- Oral contraceptive use within 30 days before screening or during study
- Long-acting estrogen/progestin use within 6 months before screening
- Unprotected intercourse within 14 days before study or during trial
- Pregnancy or lactation;
- Directly involved research staff or their family members, or subordinate researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Liyan Miao, 0512-67972858, miaolysuzhou@163.com
About this study
Official title: Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects
This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation.
Read the detailed description
The single-dose escalation clinical trial of HL-003 tablets is designed as a dose-escalation, randomized, double-blind, placebo-controlled, parallel-group study.
The multiple-dose clinical trial of HL-003 tablets is designed as a randomized, double-blind, placebo-controlled, parallel-group study. The specific dosage, dosing frequency, and duration of continuous administration will be adjusted based on the results of the single-dose escalation clinical study.
- Conditions
- Healthy Subjects
- Being tested
- HL-003 tablet Placeco, HL-003 tablet
- Keywords
- safety, tolerability, pharmacokinetic characteristics, HL-003 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-003 tablet PlacecoDrug
100mg、250mg、500mg、1000mg、1500mg，SAD
HL-003 tabletDrug
25mg、100mg、250mg、500mg、1000mg、1500mg，SAD
| Study group | Role | What they receive |
|---|---|---|
| HL-003 tablet Placeco | Placebo comparator | Not described Receives: Drug: HL-003 tablet Placeco |
| HL-003 tablet | Active comparator | Not described Receives: Drug: HL-003 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-related adverse events (TRAEs) that were intolerable (requiring intervention)
Measured: up to 3 days
Incidence of TEAEs
Measured: up to 3 days
Secondary outcomes (6)
Pharmacokinetic (PK) parameters: Tmax
Measured: up to 3 days
Pharmacokinetic (PK) parameters: Cmax
Measured: up to 3 days
Pharmacokinetic (PK) parameters: AUC0-t
Measured: up to 3 days
Pharmacokinetic (PK) parameters: AUC0-inf
Measured: up to 3 days
Pharmacokinetic (PK) parameters: t1/2
Measured: up to 3 days
Pharmacokinetic (PK) parameters: CL/F
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start28 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867393
- Sponsor's protocol ID
- HL-003-101
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06867393
- Acronym / sponsor ID
- HL-003-101
- Conditions
- Healthy Subjects
- Keywords
- safety, tolerability, pharmacokinetic characteristics, HL-003 tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Mar 2025 (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.
This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation.
Detailed description
The single-dose escalation clinical trial of HL-003 tablets is designed as a dose-escalation, randomized, double-blind, placebo-controlled, parallel-group study.
The multiple-dose clinical trial of HL-003 tablets is designed as a randomized, double-blind, placebo-controlled, parallel-group study. The specific dosage, dosing frequency, and duration of continuous administration will be adjusted based on the results of the single-dose escalation clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL-003 tablet Placeco | Placebo comparator | Drug: HL-003 tablet Placeco |
| HL-003 tablet | Active comparator | Drug: HL-003 tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender.
- Males must weigh ≥50 kg, and females must weigh ≥45 kg. The Body Mass Index (BMI) should be within the range of 19 to 26 kg/m² (including the threshold values).
- Serum creatinine levels must be within the normal range during the screening period, and the Creatinine Clearance (CCr) must be ≥90 mL/min (including the threshold value, calculated using the CKD-EPI formula.
- Comprehensive physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), and laboratory tests (including blood routine, blood biochemistry, thyroid function, parathyroid function, coagulation function, urinalysis, etc.) must all be within normal ranges or show no clinically significant abnormalities.
- Participants must agree not to plan for pregnancy during the trial and for 3 months after taking the medication, and must use reliable contraceptive methods.
Key exclusion criteria (21 listed)
- History of known allergy to the investigational drug or any of its components/related formulations; history of allergic reactions to two or more medications, foods, etc., or individuals with hypersensitive constitution;
- Subjects with special dietary requirements who cannot comply with standardized meals;
- History of frequent nausea or vomiting from any cause;
- QTcF interval >450 msec (calculation formula in Appendix 14-3);
- Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody;
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 |
|---|---|---|
| HL-003 tablet Placeco100mg、250mg、500mg、1000mg、1500mg，SAD | Drug | HL-003 tablet Placeco |
| HL-003 tablet25mg、100mg、250mg、500mg、1000mg、1500mg，SAD | Drug | HL-003 tablet |
Primary outcome
Incidence and severity of treatment-related adverse events (TRAEs) that were intolerable (requiring intervention)
Time frame: up to 3 days
Incidence of TEAEs
Time frame: up to 3 days
6 secondary outcomes
Pharmacokinetic (PK) parameters: Tmax
Time frame: up to 3 days
Pharmacokinetic (PK) parameters: Cmax
Time frame: up to 3 days
Pharmacokinetic (PK) parameters: AUC0-t
Time frame: up to 3 days
Pharmacokinetic (PK) parameters: AUC0-inf
Time frame: up to 3 days
Pharmacokinetic (PK) parameters: t1/2
Time frame: up to 3 days
Pharmacokinetic (PK) parameters: CL/F
Time frame: up to 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
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 HL-003 tablet Placeco and HL-003 tablet in people with Healthy Subjects, run by Shanghai Kechow Pharma, Inc. 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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-related adverse events (TRAEs) that were intolerable (requiring intervention) (time frame: up to 3 days). The study lists 2 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 10 Mar 2025.