HealthyPhase 1NCT07040046
HS-10542 Study in Healthy Participants
A Phase 1 study testing HS-10542 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HS-10542
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 31 Mar 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 64 years of age (critical values inclusive) when signing the informed consent form.
- Body mass index (BMI = weight/height2) ≥ 19 kg/m2 and ≤ 28 kg/m2 at screening, and body weight ≥ 50 kg for men and ≥ 45 kg for women.
- Physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound and anteroposterior and lateral chest X-ray (or CT) examination showed no abnormality, or slight abnormality but with no clinical significance as judged by the investigator, or slight abnormality but with controllable risk as judged by the investigator, and communication with the sponsor 's medical and pharmacological personnel is required when necessary;
- Female participants are required to agree to practice highly effective contraception from 2 weeks before screening until 60 days after the last dose:
- Male participants of childbearing potential are required to agree to practice highly effective contraception from the date of signing the informed consent until 120 days after the last dose; male participants of non-childbearing potential (e.g, having undergone effective sterilization) are required to agree to use additional highly effective contraception in the event of uncertainty about the presence of sperm.
- Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose, and if participants have previously received the above vaccines, antibody titers or vaccine manufacturer information should be provided, and booster vaccinations should be completed as needed according to local practice guidelines in the opinion of the investigator to obtain adequate protection during the trial.
- The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this trial, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily.
Who cannot join
- Consumed any caffeinated, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration.
- Consumed foods known to alter hepatic enzyme activity (eg, pitaya, grapefruit, Seville oranges, etc) and their juice drinks within 1 week before administration.
- Abnormal vital signs, physical examination, laboratory tests, 12-lead ECG, chest anteroposterior X-ray/CT examination, abdominal ultrasonography, etc. at the time of screening are clinically significant and, as assessed by the investigator, may increase the risk for the participant or affect the interpretation of the study results, which include but are not limited to:
- Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBiL) ≥ 1.5 times ULN.
- Abnormal renal function: eGFR < 60 mL/min/1.73 m2 at screening or abnormal renal function as judged by the investigator, calculated using the estimation formula of Chronic Kidney Disease Epidemiology Collaboration 2021 (CKD-EPI): eGFR (mL/min/1.73 m2) .
- Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula [QT/RR0.33]) > 450 msec for males and > 470 msec for females; or other clinically significant abnormalities as judged by the investigator.
Show all 24Show fewer
- Positive hepatitis B virus surface antigen (HBsAg), or negative HBsAg but positive hepatitis B core antibody (HBcAb), or positive HCV Ab, or positive result of any test for HIV antibody or Treponema pallidum-specific antibody at screening and is assessed by the investigator as inappropriate to participate in this trial.
- participants with inactive, active or latent tuberculosis infection (indicated by tuberculosis on chest X-ray or CT, or positive T-SPOT.TB result) at screening who are assessed as inappropriate for participation in this trial by the investigator.
- Women with a positive blood pregnancy test result at screening, breastfeeding women, or participants planning to become pregnant during the trial.
- Used any systemic medication or food (e.g, prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, special medical supplies, formulas, etc) that could affect the metabolism of investigational drug during the washout period or 5 half-lives (whichever is longer) of a particular drug prior to screening, or participants who are unwilling to undergo washout and discontinue such medication throughout the trial and are assessed as inappropriate for participation in this trial by the investigator. Washout periods for systemic medications or food are detailed in Section 6.7.
- Those who have been vaccinated with vaccines other than those specified in this protocol within 1 month before screening or are scheduled to be vaccinated within 1 month after the end of the administration.
- Those who have participated in a clinical trial involving an intervention with another drug or medical device and received an investigational product or use of a medical device within 1 month prior to screening or within 7 half-lives of the other investigational product, whichever is longer.
- Those who have donated blood or lost blood ≥ 450 mL within 3 months prior to screening, or planning to donate blood during the trial and at the end or within 3 months of the trial.
- Those who have a known history of smoking (> 5 cigarettes per day on average) within 3 months prior to screening.
- Those with diseases or medical conditions that may affect the absorption, distribution, metabolism and excretion of oral drugs within 3 months before screening, such as inflammatory bowel disease, peptic ulcer, gastroesophageal reflux disease, chronic diarrhea, subtotal gastrectomy, etc.
- Those who have a known history of drug abuse/abuse within 6 months prior to screening, or test positive for drug abuse at screening.
- Those who have a known history of alcohol dependence (an average of ≥ 14 units of alcohol per week, each unit being equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of liquor) within 6 months prior to screening, or a positive breath alcohol test at screening.
- Those who have undergone ≥ Grade 2 surgery within 6 months before screening, or plan to have surgery or be hospitalized during the trial.
- Those who have a previous history of severe drug, food or environmental allergy, or known hypersensitivity to the active substance and excipients of the investigational product (including HS-10542 and placebo).
- Those with a previous history of capsular microorganisms (e.g., meningococcus or pneumococcus) infection, or those with a history of close contact with individuals infected with meningococcal.
- Those who have difficulty in swallowing solid preparations such as tablets and capsules.
- Participants who have difficulty in blood collection, and cannot tolerate multiple venous blood draws or have any contraindications to blood collection.
- Participants with special dietary requirements or inability to comply with the dietary requirements of the study site.
- As judged by the investigator, those have a history of or currently have any diseases or conditions that may increase the risk of their participation in the trial, affect their compliance with the protocol, or affect their completion of the trial. These include, but are not limited to, diseases or conditions related to the respiratory, circulatory, digestive, urinary, hematological, endocrine, metabolic, nervous, mental, and immune systems.
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 Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yu Cao, 18661809090, caoyu1767@126.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants
This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.
Read the detailed description
This study consists of two parts, of which the Part I consists of the single ascending dose (SAD) study and the food effect (FE) study, while the Part II consists of the multiple ascending dose (MAD) study. The Part I and Part II form this randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK and PD characteristics, as well as the food effect on pharmacokinetics of HS-10542 in Chinese healthy adult participants after single and multiple oral doses.
- Conditions
- Healthy
- Being tested
- HS-10542, HS-10542 Placebo
- Keywords
- HS-10542, phase 1, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10542Drug
- SAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1.
- Food Effect [FE] study：HS-10542 capsule (in one predefined dose cohort ) will be administered orally once on Day 15.
HS-10542 PlaceboDrug
SAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1
HS-10542Drug
MAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.
HS-10542 PlaceboDrug
MAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1：HS-10542 SAD：HS-10542 capsule | Experimental | Not described Receives: Drug: HS-10542 |
| Cohort2：HS-10542 Placebo SAD：HS-10542 capsule placebo | Placebo comparator | Not described Receives: Drug: HS-10542 Placebo |
| Cohort3：HS-10542 MAD：HS-10542 capsule | Experimental | Not described Receives: Drug: HS-10542 |
| Cohort4：HS-10542 Placebo MAD：HS-10542 capsule placebo | Placebo comparator | Not described Receives: Drug: HS-10542 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results
The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to withdrawal from the study, as well as their correlation with the investigational drug.And the changes in clinical test and examination results before and after administration
Measured: From screening to day 11 or day 21.
Secondary outcomes (11)
Pharmacokinetics (PK) parameters：Observed maximum plasma concentration（Cmax）
The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD) and food effect (FE) studies
Measured: up to 240 hours after dosing
Pharmacokinetics (PK) parameters：Time to reach maximum plasma concentration(Tmax）
The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD) and food effect (FE) studies
Measured: up to 240 hours after dosing
Pharmacokinetics (PK) parameters：area under the concentration-time curve from time 0 to time t of last measurable concentration( AUC0-t)
The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) studies
Measured: up to 240 hours after dosing
PK parameters: Maximum plasma concentration at steady state (Css, max)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: time to Css, max (Tss, max)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Minimum plasma concentration at steady state (Css, min)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Apparent clearance at steady state (CLss/F)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Apparent volume of distribution at steady state (Vss/F)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Degree of accumulation after multiple doses (Rac)
The plasma PK parameters to be determined after the last dose in the MAD study
Measured: up to 240 hours after dosing
PK parameters: Elimination half-life (t½)
The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) studies
Measured: up to 240 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start16 May 2025
- Primary completion4 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
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
- NCT07040046
- Sponsor's protocol ID
- HS-10542-101
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 26 Jun 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07040046
- Acronym / sponsor ID
- HS-10542-101
- Conditions
- Healthy
- Keywords
- HS-10542, phase 1, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 4 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Jun 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 is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.
Detailed description
This study consists of two parts, of which the Part I consists of the single ascending dose (SAD) study and the food effect (FE) study, while the Part II consists of the multiple ascending dose (MAD) study. The Part I and Part II form this randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK and PD characteristics, as well as the food effect on pharmacokinetics of HS-10542 in Chinese healthy adult participants after single and multiple oral doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1：HS-10542 SAD：HS-10542 capsule | Experimental | Drug: HS-10542 |
| Cohort2：HS-10542 Placebo SAD：HS-10542 capsule placebo | Placebo comparator | Drug: HS-10542 Placebo |
| Cohort3：HS-10542 MAD：HS-10542 capsule | Experimental | Drug: HS-10542 |
| Cohort4：HS-10542 Placebo MAD：HS-10542 capsule placebo | Placebo comparator | Drug: HS-10542 Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 64 years of age (critical values inclusive) when signing the informed consent form.
- Body mass index (BMI = weight/height2) ≥ 19 kg/m2 and ≤ 28 kg/m2 at screening, and body weight ≥ 50 kg for men and ≥ 45 kg for women.
- Physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound and anteroposterior and lateral chest X-ray (or CT) examination showed no abnormality, or slight abnormality but with no clinical significance as judged by the investigator, or slight abnormality but with controllable risk as judged by the investigator, and communication with the sponsor 's medical and pharmacological personnel is required when necessary;
- Female participants are required to agree to practice highly effective contraception from 2 weeks before screening until 60 days after the last dose:
- Male participants of childbearing potential are required to agree to practice highly effective contraception from the date of signing the informed consent until 120 days after the last dose; male participants of non-childbearing potential (e.g, having undergone effective sterilization) are required to agree to use additional highly effective contraception in the event of uncertainty about the presence of sperm.
Key exclusion criteria (24 listed)
- Consumed any caffeinated, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration.
- Consumed foods known to alter hepatic enzyme activity (eg, pitaya, grapefruit, Seville oranges, etc) and their juice drinks within 1 week before administration.
- Abnormal vital signs, physical examination, laboratory tests, 12-lead ECG, chest anteroposterior X-ray/CT examination, abdominal ultrasonography, etc. at the time of screening are clinically significant and, as assessed by the investigator, may increase the risk for the participant or affect the interpretation of the study results, which include but are not limited to:
- Positive hepatitis B virus surface antigen (HBsAg), or negative HBsAg but positive hepatitis B core antibody (HBcAb), or positive HCV Ab, or positive result of any test for HIV antibody or Treponema pallidum-specific antibody at screening and is assessed by the investigator as inappropriate to participate in this trial.
- participants with inactive, active or latent tuberculosis infection (indicated by tuberculosis on chest X-ray or CT, or positive T-SPOT.TB result) at screening who are assessed as inappropriate for participation in this trial by the investigator.
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-105421. SAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1. 2. Food Effect [FE] study：HS-10542 capsule (in one predefined dose cohort ) will be administered orally once on Day 15. | Drug | Cohort1：HS-10542 SAD：HS-10542 capsule |
| HS-10542 PlaceboSAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 | Drug | Cohort2：HS-10542 Placebo SAD：HS-10542 capsule placebo |
| HS-10542MAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10. | Drug | Cohort3：HS-10542 MAD：HS-10542 capsule |
| HS-10542 PlaceboMAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10. | Drug | Cohort4：HS-10542 Placebo MAD：HS-10542 capsule placebo |
Primary outcome
Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results
Time frame: From screening to day 11 or day 21.
The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to withdrawal from the study, as well as their correlation with the investigational drug.And the changes in clinical test and examination results before and after administration
11 secondary outcomes
Pharmacokinetics (PK) parameters：Observed maximum plasma concentration（Cmax）
Time frame: up to 240 hours after dosing
Pharmacokinetics (PK) parameters：Time to reach maximum plasma concentration(Tmax）
Time frame: up to 240 hours after dosing
Pharmacokinetics (PK) parameters：area under the concentration-time curve from time 0 to time t of last measurable concentration( AUC0-t)
Time frame: up to 240 hours after dosing
PK parameters: Maximum plasma concentration at steady state (Css, max)
Time frame: up to 240 hours after dosing
PK parameters: time to Css, max (Tss, max)
Time frame: up to 240 hours after dosing
PK parameters: Minimum plasma concentration at steady state (Css, min)
Time frame: up to 240 hours after dosing
PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss)
Time frame: up to 240 hours after dosing
PK parameters: Apparent clearance at steady state (CLss/F)
Time frame: up to 240 hours after dosing
PK parameters: Apparent volume of distribution at steady state (Vss/F)
Time frame: up to 240 hours after dosing
PK parameters: Degree of accumulation after multiple doses (Rac)
Time frame: up to 240 hours after dosing
PK parameters: Elimination half-life (t½)
Time frame: up to 240 hours after dosing
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 26 Jun 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 HS-10542 in people with Healthy, 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 7 inclusion and 24 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 26 Jun 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?
Contact Yu Cao (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results (time frame: From screening to day 11 or day 21.). 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 26 Jun 2025.