Healthy ParticipantsPhase 1HS-20118-111NCT07896915
A Study to Evaluate the Pharmacokinetic Characteristics of HS-20118 Under Different Dosing Conditions in Healthy Participants
A Phase 1 study testing HS-20118 in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, randomized, four-period dosing clinical study designed to evaluate the pharmacokinetic characteristics of HS-20118 under different dosing conditions in healthy participants. It is planned to enroll 32 healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- HS-20118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 25 Dec 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants fully understand the purpose, nature, methods, and potential adverse events of the study, participate voluntarily, and have signed the written informed consent form.
- Adult male and female participants aged 18 to 45 years (inclusive), on the date of signing the informed consent form.
- Body weight ≥ 50.0 kg for male participants, ≥ 45.0 kg for female participants, and ≤ 100.0 kg for both; body mass index (BMI) within the range of 18.0 to 26.0 kg/m2, inclusive.
- Agrees to have no procreative plans or plans for sperm/oocyte donation during the study and for 6 months after the last dose of study drug, and voluntarily agrees to use highly effective methods of contraception.
Who cannot join
- Clinically significant abnormalities in physical examination, vital signs, clinical laboratory tests, 12-lead electrocardiogram (ECG), abdominal color Doppler ultrasound, chest X-ray, or CT scan during the screening period.
- Past history of, or current, serious diseases involving the neurological, psychiatric, gastrointestinal (digestive), cardiovascular (circulatory), respiratory, or urinary systems, or any new-onset illness prior to the administration of the investigational product, which, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
- Active infection (including chronic or localized infection) within 7 days prior to screening, history of recurrent infections with underlying diseases predisposing to infection, or history of opportunistic infections.
- Use of any prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or health supplements (excluding topical preparations exerting localized effects) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to the first dose.
- Receipt of any vaccine within 4 weeks prior to the first dose, or plan to receive any vaccine during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of HS-20118 Under Different Dosing Conditions in Healthy Participants
This study is a single-center, open-label, randomized, four-period dosing clinical study designed to evaluate the pharmacokinetic characteristics of HS-20118 under different dosing conditions in healthy participants. It is planned to enroll 32 healthy participants.
Read the detailed description
This is a single-center, open-label, randomized, 4-period dosing clinical study. Eligible participants will be randomized into two groups: Group 1 and Group 2. A 42-day washout period will separate each consecutive period.
Dosing Conditions for Group 1:
Participants will be required to fast overnight for at least 10 hours prior to dosing across all 4 periods. In each period, a dose of 400 mg will be administered with approximately 180 mL of water. Water intake will be restricted from 2 hours pre-dose until 2 hours post-dose (except for the water used for dosing and beverages provided with the low-fat/high-fat meals). In Period 1, a low-fat meal will be consumed 1 hour post-dose; in Period 2, a low-fat meal will be consumed 30 minutes post-dose; in Period 3, a low-fat meal will be consumed 2 hours post-dose; and in Period 4, a high-fat meal will be consumed 30 minutes post-dose.
Dosing Conditions for Group 2:
In each period, a dose of 400 mg will be administered with approximately 180 mL of water, and water intake will be restricted from 2 hours pre-dose until 2 hours post-dose (except for the water used for dosing and beverages provided with the low-fat/high-fat meals).
Periods 1 to 3: Participants will fast for 6 hours prior to dosing in Periods 1 and 3, and for 4 hours prior to dosing in Period 2. Prior to the initiation of the pre-dose fast in each period, a low-fat meal must be completed within 15 minutes, following a fast of at least 4 hours before this meal. A low-fat meal will be consumed 2 hours post-dose in Periods 1 and 2, and 30 minutes post-dose in Period 3.
Period 4: Participants will fast for 6 hours prior to dosing. A high-fat meal must be completed within 30 minutes prior to the initiation of the pre-dose fast, following a fast of at least 4 hours before this meal. A high-fat meal will be consumed 30 minutes post-dose.
- Conditions
- Healthy Participants
- Being tested
- HS-20118
- Keywords
- Phase I, Dosing Conditions, HS-20118, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20118Drug
HS-20118 tablets will be administered orally as a single dose of 400 mg (two 200 mg tablets) with approximately 180 mL of water in each of the 4 treatment periods, separated by a washout period of at least 42 days. In each period, the drug will be administered under specific dietary and fasting conditions.
HS-20118Drug
HS-20118 tablets will be administered orally as a single dose of 400 mg (two 200 mg tablets) with approximately 180 mL of water in each of the 4 treatment periods, separated by a washout period of at least 42 days. In each period, the drug will be administered under specific dietary and fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (sequence1) | Experimental | Not described Receives: Drug: HS-20118 |
| Group 2 (sequence 2) | Experimental | Not described Receives: Drug: HS-20118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
Tmax of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
AUC0-t of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
AUC0-inf of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
t1/2 of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
CL/F of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
Vd/F of HS-20118 under different administration conditions
Measured: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
Secondary outcomes (2)
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and Safety Abnormalities
Incidence, seriousness, and severity of adverse events will be evaluated. Safety assessments will include vital signs, 12-lead electrocardiogram (ECG) parameters, physical examinations, and clinical laboratory tests.
Measured: Day 1 up to Day 183
Incidence of Anti-drug antibody (ADA)
Blood samples will be analyzed for the presence of ADAs against HS-20118
Measured: Pre-dose on Day 1 up to Day 162
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start3 Aug 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896915
- Sponsor's protocol ID
- HS-20118-111
- Acronym
- HS-20118-111
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of HS-20118 Under Different Dosing Conditions in Healthy Participants
- ClinicalTrials.gov ID
- NCT07896915
- Acronym / sponsor ID
- HS-20118-111 / HS-20118-111
- Conditions
- Healthy Participants
- Keywords
- Phase I, Dosing Conditions, HS-20118, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (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 study is a single-center, open-label, randomized, four-period dosing clinical study designed to evaluate the pharmacokinetic characteristics of HS-20118 under different dosing conditions in healthy participants. It is planned to enroll 32 healthy participants.
Detailed description
This is a single-center, open-label, randomized, 4-period dosing clinical study. Eligible participants will be randomized into two groups: Group 1 and Group 2. A 42-day washout period will separate each consecutive period.
Dosing Conditions for Group 1:
Participants will be required to fast overnight for at least 10 hours prior to dosing across all 4 periods. In each period, a dose of 400 mg will be administered with approximately 180 mL of water. Water intake will be restricted from 2 hours pre-dose until 2 hours post-dose (except for the water used for dosing and beverages provided with the low-fat/high-fat meals). In Period 1, a low-fat meal will be consumed 1 hour post-dose; in Period 2, a low-fat meal will be consumed 30 minutes post-dose; in Period 3, a low-fat meal will be consumed 2 hours post-dose; and in Period 4, a high-fat meal will be consumed 30 minutes post-dose.
Dosing Conditions for Group 2:
In each period, a dose of 400 mg will be administered with approximately 180 mL of water, and water intake will be restricted from 2 hours pre-dose until 2 hours post-dose (except for the water used for dosing and beverages provided with the low-fat/high-fat meals).
Periods 1 to 3: Participants will fast for 6 hours prior to dosing in Periods 1 and 3, and for 4 hours prior to dosing in Period 2. Prior to the initiation of the pre-dose fast in each period, a low-fat meal must be completed within 15 minutes, following a fast of at least 4 hours before this meal. A low-fat meal will be consumed 2 hours post-dose in Periods 1 and 2, and 30 minutes post-dose in Period 3.
Period 4: Participants will fast for 6 hours prior to dosing. A high-fat meal must be completed within 30 minutes prior to the initiation of the pre-dose fast, following a fast of at least 4 hours before this meal. A high-fat meal will be consumed 30 minutes post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (sequence1) | Experimental | Drug: HS-20118 |
| Group 2 (sequence 2) | Experimental | Drug: HS-20118 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants fully understand the purpose, nature, methods, and potential adverse events of the study, participate voluntarily, and have signed the written informed consent form.
- Adult male and female participants aged 18 to 45 years (inclusive), on the date of signing the informed consent form.
- Body weight ≥ 50.0 kg for male participants, ≥ 45.0 kg for female participants, and ≤ 100.0 kg for both; body mass index (BMI) within the range of 18.0 to 26.0 kg/m2, inclusive.
- Agrees to have no procreative plans or plans for sperm/oocyte donation during the study and for 6 months after the last dose of study drug, and voluntarily agrees to use highly effective methods of contraception.
Key exclusion criteria (5 listed)
- Clinically significant abnormalities in physical examination, vital signs, clinical laboratory tests, 12-lead electrocardiogram (ECG), abdominal color Doppler ultrasound, chest X-ray, or CT scan during the screening period.
- Past history of, or current, serious diseases involving the neurological, psychiatric, gastrointestinal (digestive), cardiovascular (circulatory), respiratory, or urinary systems, or any new-onset illness prior to the administration of the investigational product, which, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
- Active infection (including chronic or localized infection) within 7 days prior to screening, history of recurrent infections with underlying diseases predisposing to infection, or history of opportunistic infections.
- Use of any prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or health supplements (excluding topical preparations exerting localized effects) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to the first dose.
- Receipt of any vaccine within 4 weeks prior to the first dose, or plan to receive any vaccine during the study.
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 |
|---|---|---|
| HS-20118HS-20118 tablets will be administered orally as a single dose of 400 mg (two 200 mg tablets) with approximately 180 mL of water in each of the 4 treatment periods, separated by a washout period of at least 42 days. In each period, the drug will be administered under specific dietary and fasting conditions. | Drug | Group 1 (sequence1) |
| HS-20118HS-20118 tablets will be administered orally as a single dose of 400 mg (two 200 mg tablets) with approximately 180 mL of water in each of the 4 treatment periods, separated by a washout period of at least 42 days. In each period, the drug will be administered under specific dietary and fasting conditions. | Drug | Group 2 (sequence 2) |
Primary outcome
Cmax of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
Tmax of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
AUC0-t of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
AUC0-inf of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
t1/2 of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
CL/F of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
Vd/F of HS-20118 under different administration conditions
Time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4
2 secondary outcomes
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and Safety Abnormalities
Time frame: Day 1 up to Day 183
Incidence of Anti-drug antibody (ADA)
Time frame: Pre-dose on Day 1 up to Day 162
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 27 Oct 2026.
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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 HS-20118 in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 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?
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?
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?
Cmax of HS-20118 under different administration conditions (time frame: Pre-dose up to Day 36 post-dose in Period 1, up to Day 78 in Period 2, up to Day 120 in Period 3, and up to Day 162 in Period 4). The study lists 7 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 27 Oct 2026.