COVID-19Phase 1/2NCT05779579
Study of HS-10517 in Chinese Adult Participants
A Phase 1/2 study testing HS-10517 Dose 1, HS-10517 Dose 2 and HS-10517 Dose 3 in people with COVID-19, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Phase I/II, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and primary efficacy of HS-10517 in Chinese adult participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- HS-10517 Dose 1, HS-10517 Dose 2 and HS-10517 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Jun 2023
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
- The age at the time of signing the informed consent is between 18 and 45 years old (including the critical value)
- Subjects with negative COVID-19 nucleic acid detection in screening period;
- The body mass index (BMI=body weight [kg]/height2 [m2]) at screening is 19~27kg/m2 (including the critical value), and the weight of men is ≥ 50kg, and that of women is ≥ 40kg;
- The blood pregnancy test of female subjects in the screening period and the baseline period is negative;
- Female subjects must agree to take effective contraceptive measures from the date of signing the informed consent form to 30 days after the last administration:
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- Those with fertility: from the date of signing the informed consent form to 30 days after the last administration, ① avoid pregnancy, ② if having sex with the opposite sex, agree to continue to use one or more forms of effective contraception (such as verified intrauterine devices, bilateral tubal ligation or correct use of condoms, excluding any form of hormonal contraceptives). If the male partner has undergone an effective sterilization operation, additional effective contraception measures should be taken when the sperm is uncertain);
- Non-fertility: ① Postmenopausal (spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH>40 IU/L, without other obvious pathological or physiological reasons) before screening; Or ② documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
- Male subjects (including their female partners) must agree to take effective contraceptive measures from the date of signing the informed consent form to 30 days after the last administration:
- Those who are fertile must agree to use condoms correctly. If their female partners are women of child-bearing age and have fertility (have not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy and have no medical proven ovarian failure), their female partners must take effective contraceptive measures (such as oral/injection/vaginal or implantable hormone contraceptives, or other physical barrier, surgery and other female contraceptive methods) within 30 days after the last administration;
- Those who are infertile, such as those who have undergone effective sterilization operations, take additional effective contraceptive measures when they are not sure whether they have sperm);
- Male subjects agree to avoid donating sperm within 30 days from the initiation of drug administration until the last administration.
- Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
- The age at the time of signing the informed consent is ≥ 18 years old;
- In the first 2 days (48 hours) before randomization, COVID-19 nucleic acid detected by RT-PCR is positive;
- During the screening period, the subject is assessed by the research doctor as a patient with mild to moderate COVID-19 infection;
- During the screening period, the subject is assessed by the research doctor and show symptoms/signs of COVID-19 infection for the first time within 2 days before randomization;
- At least one of targeted COVID-19 symptoms exists within the first 24 hours of randomization and meets the corresponding severity;
- Female subjects must agree to take the drug from the date of signing the informed consent form to 30 days after the last administration; Effective contraceptive measures:
- Those with fertility: from the date of signing the informed consent form to 30 days after the last administration, ① avoid pregnancy, ② if having sex with the opposite sex, agree to continue to use one or more forms of effective contraception (such as verified intrauterine devices, bilateral tubal ligation or correct use of condoms, excluding any form of hormonal contraceptives). If the male partner has undergone an effective sterilization operation, additional effective contraception measures should be taken when the sperm is uncertain);
- Male subjects (including their female partners) agree to take effective contraceptive measures from the date of signing the informed consent form to 30 days after the last administration:
- Those who are fertile must agree to use condoms correctly. If their female partners are women of child-bearing age and have fertility (have not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy and have no medical proven ovarian failure), their female partners must take effective contraceptive measures (such as oral/injection/vaginal or implantable hormone contraceptives, or other physical barrier, surgery and other female contraceptive methods) within 30 days after the last administration
- Those who are infertile, such as those who have undergone effective sterilization, take additional effective contraceptive measures when they are not sure whether they have sperm).
- The pregnancy test of female subjects in the screening period and the baseline period is negative;
- Male subjects agree to avoid donating sperm within 30 days from the start of administration until the last administration
Who cannot join
- According to the judgment of the principal investigator, the participant is accompanied with suspected COVID-19 related clinical symptoms/signs;
- During screening, those who are judged to be clinically significant by the principal investigator through medical history inquiry, physical examination, vital signs, blood oxygen saturation (SpO2), laboratory examination, 12-lead electrocardiogram (ECG), abdominal ultrasound, chest X-ray examination, etc;
- Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) are evaluated by the researcher as not suitable for this study;
- Previous major surgery, or according to the judgment of the principal investigator, there is any physiological or disease or condition that may affect the absorption of the study drug (such as gastrectomy, cholecystectomy, enterotomy, etc.);
- According to the judgment of the principal investigator, there is any physical or psychological disease or condition that may increase the risk of the test, affect the compliance of the subject with the other case, or affect the subject's completion of the test;
- Within 2 weeks or 5 half-life (whichever is longer) before screening, and during the whole study period, it is expected to take any medicine and health care products, including prescription drugs, over-the-counter drugs and Chinese herbal medicine (including oral contraceptives, external spermicide, drugs with systemic therapeutic effects through percutaneous absorption and St. John's wort);
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- Participants have participated in any clinical study or taken study drugs within 3 months before screening;
- Have a history of vaccination within 30 days before screening, or plan to have a vaccination throughout the study period;
- Difficult in blood sample collection, unable to tolerate multiple venous blood collection and any contraindication of blood sample collection;
- Large amount of blood loss or donation (more than 250mL) within 3 months before screening;
- At screening, 12-lead ECG is abnormal and had clinical significance according to the judgment of the researcher, such as the QT interval (QTcB) corrected by Bazett (formula QT/RR0.5), the absolute value of QTcB in males is more than 450ms, and the absolute value of QTcB in females is more than 470ms;
- When screening, endogenous creatinine clearance rate is less than 80mL/min, according to Cockcroft-Gault formula: endogenous creatinine clearance rate (mL/min)=(140 - age) × body weight (kg) 72 × serum creatinine concentration (mg/dL) (female × 0.85);
- During the screening period and/or the baseline period, the blood pressure and pulse are within the following range: systolic blood pressure <90 mmHg or ≥ 140 mmHg, diastolic blood pressure <60 mmHg or ≥ 90 mmHg, pulse <55 bpm or >100 bpm;
- Have a history of drug dependence or drug abuse in the past, or have a positive urine drug test during screening;
- Those who have a history of severe allergy to drugs, food and articles (including allergy to latex, dust mites, pollen, etc.), or are known to be allergic to the test drug ingredients;
- Within 2 weeks before screening, dieting or receiving dietary treatment for whatever reason, or major changes in dietary habits;
- Have a history of alcoholism in the past (drinking more than 14 units of alcohol per week on average), or drink more than 14 units of alcohol per time in the past two weeks (1 unit=285mL of beer, 25mL of spirits, 125mL of wine), or cannot stop drinking alcohol products during the test; Or positive alcohol breath test during screening;
- Those who smoke more than 5 cigarettes per day on average in the three months before screening, or who cannot stop using any tobacco products during the test;
- Within 2 weeks before screening, subjects ingested foods that may affect drug metabolism, such as grapefruit juice;
- The average daily intake of coffee, tea, cola or other caffeinated drinks exceeds 6 cups (about 250mL per cup) within 3 months before screening;
- Those who have difficulty swallowing solid preparations such as tablets;
- Female subjects are in pregnancy or lactation at the time of screening;
- This study may not be completed due to other reasons or the researcher judges that it is not suitable for participants.
- The medical condition indicates that COVID-19 causes clinical signs of severe systemic diseases, such as respiratory rate ≥ 30 times/minute, heart rate ≥ 125 times/minute, blood oxygen saturation (SpO2) ≤ 93% or PaO2/FiO2<300 mmHg within 24 hours before randomization (under indoor air conditions at rest), and it is urgent or expected to require nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation or ECMO.
- According to the judgment of the researcher, the medical condition suggests that COVID-19 may develop into severe/critical status in the next 48 hours;
- Other than COVID-19, suspected or confirmed acute systemic infection (such as combined influenza and bacterial infection) may interfere with the evaluation of the research intervention response.
- Known history of active liver disease (excluding nonalcoholic fatty liver), including acute or chronic active hepatitis B or C, primary biliary cirrhosis, Child-Pugh grade B or C or acute liver failure.
- The patient is undergoing dialysis or is known to have moderate to severe renal damage (that is, within 6 months before the screening visit, the CKD-EPI formula based on serum creatinine eGFR < 45mL/min/1.73m2).
- They received anti-COVID-19 drugs (excluding NSAIDs) within 14 days before randomization.
- Has received (within 30 days before randomization or within the half-life of 5 drugs, whichever is longer) or is expected to receive COVID-19 monoclonal antibody or COVID-19 convalescence plasma treatment during the study period.
- Any anti-COVID-19 vaccine was inoculated within 3 months before randomization.
- Subjects who have to use potent CYP3A4/5 inhibitors and/or potent CYP3A4/5 inducers from 7 days before screening to 7 days after the last administration for various reasons.
- Subjects have major diseases (such as acute myocardial infarction, stroke, malignant tumor, etc.) within 30 days before signing the informed consent form;
- Those who have difficulty swallowing solid preparations such as tablets;
- At the time of screening, the female subjects are in pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Linlin Song, 053189268311, 13335126599@189.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Primary Efficacy of HS-10517 in Chinese Adult Participants
A Phase I/II, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and primary efficacy of HS-10517 in Chinese adult participants.
- Conditions
- COVID-19
- Being tested
- HS-10517 Dose 1, HS-10517 Dose 2, HS-10517 Dose 3, HS-10517 Dose 4, Placebo
- Keywords
- HS-10517, 3CL protease inhibitor, single ascending dose, multiple ascending dose, phase 2 study, dose exploration, Chinese, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10517 Dose 1Drug
HS-10517 Dose 1+Ritonavir
HS-10517 Dose 2Drug
HS-10517 Dose 2+Ritonavir
HS-10517 Dose 3Drug
HS-10517 Dose 3+Ritonavir
HS-10517 Dose 4Drug
HS-10517 Dose 4+Ritonavir
PlaceboDrug
Dose level A of placebo
| Study group | Role | What they receive |
|---|---|---|
| HS-10517 Dose 1 | Experimental | Dose level 1 of HS-10517 Tablets，Dose 1 Receives: Drug: HS-10517 Dose 1 |
| HS-10517 Dose 2 | Experimental | Dose level 1 of HS-10517 Tablets，Dose 2 Receives: Drug: HS-10517 Dose 2 |
| HS-10517 Dose 3 | Experimental | Dose level 1 of HS-10517 Tablets，Dose 3 Receives: Drug: HS-10517 Dose 3 |
| HS-10517 Dose 4 | Experimental | Dose level 1 of HS-10517 Tablets，Dose 4 Receives: Drug: HS-10517 Dose 4 |
| Placebo Comparator | Experimental | Dose level A of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in single ascending dose (SAD)
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Measured: Day 1 to Day 5
Number of participants with clinically significant change from baseline in vital signs in SAD
Measured: Day 1 to Day 5
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Measured: Day 1 to Day 5
Number of participants with clinically significant abnormalities in laboratory examination in SAD
Measured: Day 1 to Day 5
Number of participants with clinically significant abnormalities in physical examination in SAD
Measured: Day 1 to Day 5
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in multiple ascending dose (MAD)
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Measured: Day 1 to Day 14
Number of participants with clinically significant change from baseline in vital signs in MAD
Measured: Day 1 to Day 14
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Measured: Day 1 to Day 14
Number of participants with clinically significant abnormalities in laboratory examination in MAD
Measured: Day 1 to Day 14
Number of participants with clinically significant abnormalities in physical examination in MAD
Measured: Day 1 to Day 14
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in supratherapeutic exposure (SE)
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Measured: Day 1 to Day 13
Number of participants with clinically significant change from baseline in vital signs in SE
Measured: Day 1 to Day 13
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SE
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Measured: Day 1 to Day 13
Number of participants with clinically significant abnormalities in laboratory examination in SE
Measured: Day 1 to Day 13
Number of participants with clinically significant abnormalities in physical examination in SE
Measured: Day 1 to Day 13
Percentage of participants with a negative RT-PCR test through day 5-modified intent-to-treat (mITT) population.
Measured: Day 1 to Day 5
Secondary outcomes (39)
Maximum plasma concentration (Cmax) in SAD
The maximum observed plasma concentration [Cmax] is estimated based on the plasma concentrations.
Measured: Day 1 to Day 5
Time for Cmax (tmax) in SAD
Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
Measured: Day 1 to Day 5
Area under the concentration time profile from time 0 to the time of last quantifiable plasma concentration (AUC0-last) in SAD
AUC0-last is summarized by dosing regimen and determined by linear/log trapezoidal method.
Measured: Day 1 to Day 5
Area under the concentration time profile from time 0 to infinity (AUC0-inf) in SAD
AUC0-inf is summarized by dosing regimen and determined by linear/log trapezoidal method.
Measured: Day 1 to Day 5
Terminal rate constant (λz) in SAD
Measured: Day 1 to Day 5
Terminal half-life (t1/2) in SAD
Measured: Day 1 to Day 5
Apparent clearance (CL/F) in SAD
Measured: Day 1 to Day 5
Apparent volume of distribution (Vd/F) in SAD
Measured: Day 1 to Day 5
Mean residence time (MRT) in SAD symptoms to the sustained clinical resolution within 28 days（Phase II）
Measured: Day 1 to Day 5
Maximum plasma concentration (Cmax) in first dose of MAD
The maximum observed plasma concentration [Cmax] is estimated based on the plasma concentrations.
Measured: Day 1 to Day 14
Time for Cmax (tmax) in first dose of MAD
Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
Measured: Day 1 to Day 14
Area under the concentration time profile from time 0 to 24 hours in first dose of MAD
AUC0-24 is summarized by dosing regimen and determined by linear/log trapezoidal method.
Measured: Day 1 to Day 14
Area under the concentration time profile from time 0 to 12 hours in first dose of MAD
AUC0-12 is summarized by dosing regimen and determined by linear/log trapezoidal method.
Measured: Day 1 to Day 14
Maximum plasma concentration at steady state (Css,max) in last dose of MAD
Measured: Day 1 to Day 14
Time for Cmax at steady state (tss,max) in last dose of MAD
Measured: Day 1 to Day 14
Minimum plasma concentration at steady state (Css,min) in last dose of MAD
Measured: Day 1 to Day 14
Area under the concentration time profile in one dosing interval at steady state (AUCss) in last dose of MAD
Measured: Day 1 to Day 14
Apparent clearance at steady state (CLss/F) in last dose of MAD
Measured: Day 1 to Day 14
Degree of accumulation after multiple doses (RAC, including RAUC and RCmax) in last dose of MAD
Measured: Day 1 to Day 14
Maximum plasma concentration (Cmax) in SE
The maximum observed plasma concentration [Cmax] is estimated based on the plasma concentrations.
Measured: Day 1 to Day 13
Time for Cmax (tmax) in SE
Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence
Measured: Day 1 to Day 13
Area under the concentration time profile from time 0 to the time of last quantifiable plasma concentration (AUC0-last) in SE
AUC0-last is summarized by dosing regimen and determined by linear/log trapezoidal method
Measured: Day 1 to Day 13
Area under the concentration time profile from time 0 to infinity (AUC0-inf) in SE
AUC0-inf is summarized by dosing regimen and determined by linear/log trapezoidal method
Measured: Day 1 to Day 13
Terminal rate constant (λz) in SE
Measured: Day 1 to Day 13
Terminal half-life (t1/2) in SE
Measured: Day 1 to Day 13
Apparent clearance (CL/F) in SE
Measured: Day 1 to Day 13
Apparent volume of distribution (Vd/F) in SE
Measured: Day 1 to Day 13
Mean residence time (MRT) in SE
Measured: Day 1 to Day 13
Time to sustained resolution of 11 COVID-19 symptoms within 28 days
All of the 11 COVID-19-related symptoms consist of stuffy or running nose, sore throat, shortness of breath, cough, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Sustained resolution is defined as when all targeted symptoms were scored as 0 for 2 consecutive days.
Measured: Day 1 to Day 28
Change of viral load over time compared to baseline
Measured: Day 1 to Day 28
Time to the first negative RT-PCR test
Measured: Day 1 to Day 28
Virological response at each time point after randomization
virological response means the rate of negative RT-PCR test
Measured: Day 1 to Day 28
Time to sustained alleviation of 11 targeted COVID-19 signs/symptoms within 28 days
Sustained alleviation of 11 targeted COVID-19 signs/symptoms was defined as the event occurring on the first 2 consecutive days when 11 targeted symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 2 consecutive-day period was considered date of first event. Time to sustained recovery [event] was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution [censored], time was calculated as censoring date [last date on which symptom recovery was assessed] minus first dose date plus 1 or Day 25 whichever occurred first.
Measured: Day 1 to Day 28
Time to sustained resolution of each targeted COVID-19 symptom
Measured: Day 1 to Day 28
Change of the score of each COVID-19 symptom
11 targeted COVID-19 related clinical symptoms) from baseline up to 28 days
Measured: Day 1 to Day 28
Proportion of severe cases within 28 days
All 4 inclusion criteria should be met in severe cases: positive RT-PCR test; respiratory distress [respiratory rate > 30 times/min]; hypoxia [resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg]; COVID-19 featured lung lesions in chest X-ray image.
Measured: Day 1 to Day 28
The plasma concentration of HS-10517 in COVID-19 patients in phase II study
Measured: Day 1 to Day 7
Population apparent clearance (CL/F) of COVID-19 patients in phase II study
Measured: Day 1 to Day 7
Population apparent volume of distribution (Vd/F) of COVID-19 patients in phase II study
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2023
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 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
- NCT05779579
- Sponsor's protocol ID
- HS-10517-101
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 3 Apr 2023
- 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Primary Efficacy of HS-10517 in Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT05779579
- Acronym / sponsor ID
- HS-10517-101
- Conditions
- COVID-19
- Keywords
- HS-10517, 3CL protease inhibitor, single ascending dose, multiple ascending dose, phase 2 study, dose exploration, Chinese, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Mar 2023 (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 I/II, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and primary efficacy of HS-10517 in Chinese adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HS-10517 Dose 1 | Experimental | Drug: HS-10517 Dose 1Dose level 1 of HS-10517 Tablets，Dose 1 |
| HS-10517 Dose 2 | Experimental | Drug: HS-10517 Dose 2Dose level 1 of HS-10517 Tablets，Dose 2 |
| HS-10517 Dose 3 | Experimental | Drug: HS-10517 Dose 3Dose level 1 of HS-10517 Tablets，Dose 3 |
| HS-10517 Dose 4 | Experimental | Drug: HS-10517 Dose 4Dose level 1 of HS-10517 Tablets，Dose 4 |
| Placebo Comparator | Experimental | Drug: PlaceboDose level A of placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
- The age at the time of signing the informed consent is between 18 and 45 years old (including the critical value)
- Subjects with negative COVID-19 nucleic acid detection in screening period;
- The body mass index (BMI=body weight [kg]/height2 [m2]) at screening is 19~27kg/m2 (including the critical value), and the weight of men is ≥ 50kg, and that of women is ≥ 40kg;
- The blood pregnancy test of female subjects in the screening period and the baseline period is negative;
Key exclusion criteria (35 listed)
- According to the judgment of the principal investigator, the participant is accompanied with suspected COVID-19 related clinical symptoms/signs;
- During screening, those who are judged to be clinically significant by the principal investigator through medical history inquiry, physical examination, vital signs, blood oxygen saturation (SpO2), laboratory examination, 12-lead electrocardiogram (ECG), abdominal ultrasound, chest X-ray examination, etc;
- Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) are evaluated by the researcher as not suitable for this study;
- Previous major surgery, or according to the judgment of the principal investigator, there is any physiological or disease or condition that may affect the absorption of the study drug (such as gastrectomy, cholecystectomy, enterotomy, etc.);
- According to the judgment of the principal investigator, there is any physical or psychological disease or condition that may increase the risk of the test, affect the compliance of the subject with the other case, or affect the subject's completion of the test;
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-10517 Dose 1HS-10517 Dose 1+Ritonavir | Drug | HS-10517 Dose 1 |
| HS-10517 Dose 2HS-10517 Dose 2+Ritonavir | Drug | HS-10517 Dose 2 |
| HS-10517 Dose 3HS-10517 Dose 3+Ritonavir | Drug | HS-10517 Dose 3 |
| HS-10517 Dose 4HS-10517 Dose 4+Ritonavir | Drug | HS-10517 Dose 4 |
| PlaceboDose level A of placebo | Drug | Placebo Comparator |
Primary outcome
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in single ascending dose (SAD)
Time frame: Day 1 to Day 5
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Number of participants with clinically significant change from baseline in vital signs in SAD
Time frame: Day 1 to Day 5
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
Time frame: Day 1 to Day 5
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Number of participants with clinically significant abnormalities in laboratory examination in SAD
Time frame: Day 1 to Day 5
Number of participants with clinically significant abnormalities in physical examination in SAD
Time frame: Day 1 to Day 5
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in multiple ascending dose (MAD)
Time frame: Day 1 to Day 14
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Number of participants with clinically significant change from baseline in vital signs in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
Time frame: Day 1 to Day 14
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Number of participants with clinically significant abnormalities in laboratory examination in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant abnormalities in physical examination in MAD
Time frame: Day 1 to Day 14
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in supratherapeutic exposure (SE)
Time frame: Day 1 to Day 13
The definition of adverse event [AE] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event [SAE] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Number of participants with clinically significant change from baseline in vital signs in SE
Time frame: Day 1 to Day 13
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SE
Time frame: Day 1 to Day 13
Criteria for clinically significant changes in 12-lead ECG are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled 12-lead ECG.
Number of participants with clinically significant abnormalities in laboratory examination in SE
Time frame: Day 1 to Day 13
Number of participants with clinically significant abnormalities in physical examination in SE
Time frame: Day 1 to Day 13
Percentage of participants with a negative RT-PCR test through day 5-modified intent-to-treat (mITT) population.
Time frame: Day 1 to Day 5
39 secondary outcomes
Maximum plasma concentration (Cmax) in SAD
Time frame: Day 1 to Day 5
Time for Cmax (tmax) in SAD
Time frame: Day 1 to Day 5
Area under the concentration time profile from time 0 to the time of last quantifiable plasma concentration (AUC0-last) in SAD
Time frame: Day 1 to Day 5
Area under the concentration time profile from time 0 to infinity (AUC0-inf) in SAD
Time frame: Day 1 to Day 5
Terminal rate constant (λz) in SAD
Time frame: Day 1 to Day 5
Terminal half-life (t1/2) in SAD
Time frame: Day 1 to Day 5
Apparent clearance (CL/F) in SAD
Time frame: Day 1 to Day 5
Apparent volume of distribution (Vd/F) in SAD
Time frame: Day 1 to Day 5
Mean residence time (MRT) in SAD symptoms to the sustained clinical resolution within 28 days（Phase II）
Time frame: Day 1 to Day 5
Maximum plasma concentration (Cmax) in first dose of MAD
Time frame: Day 1 to Day 14
Time for Cmax (tmax) in first dose of MAD
Time frame: Day 1 to Day 14
Area under the concentration time profile from time 0 to 24 hours in first dose of MAD
Time frame: Day 1 to Day 14
Area under the concentration time profile from time 0 to 12 hours in first dose of MAD
Time frame: Day 1 to Day 14
Maximum plasma concentration at steady state (Css,max) in last dose of MAD
Time frame: Day 1 to Day 14
Time for Cmax at steady state (tss,max) in last dose of MAD
Time frame: Day 1 to Day 14
Minimum plasma concentration at steady state (Css,min) in last dose of MAD
Time frame: Day 1 to Day 14
Area under the concentration time profile in one dosing interval at steady state (AUCss) in last dose of MAD
Time frame: Day 1 to Day 14
Apparent clearance at steady state (CLss/F) in last dose of MAD
Time frame: Day 1 to Day 14
Degree of accumulation after multiple doses (RAC, including RAUC and RCmax) in last dose of MAD
Time frame: Day 1 to Day 14
Maximum plasma concentration (Cmax) in SE
Time frame: Day 1 to Day 13
Time for Cmax (tmax) in SE
Time frame: Day 1 to Day 13
Area under the concentration time profile from time 0 to the time of last quantifiable plasma concentration (AUC0-last) in SE
Time frame: Day 1 to Day 13
Area under the concentration time profile from time 0 to infinity (AUC0-inf) in SE
Time frame: Day 1 to Day 13
Terminal rate constant (λz) in SE
Time frame: Day 1 to Day 13
Terminal half-life (t1/2) in SE
Time frame: Day 1 to Day 13
Apparent clearance (CL/F) in SE
Time frame: Day 1 to Day 13
Apparent volume of distribution (Vd/F) in SE
Time frame: Day 1 to Day 13
Mean residence time (MRT) in SE
Time frame: Day 1 to Day 13
Time to sustained resolution of 11 COVID-19 symptoms within 28 days
Time frame: Day 1 to Day 28
Change of viral load over time compared to baseline
Time frame: Day 1 to Day 28
Time to the first negative RT-PCR test
Time frame: Day 1 to Day 28
Virological response at each time point after randomization
Time frame: Day 1 to Day 28
Time to sustained alleviation of 11 targeted COVID-19 signs/symptoms within 28 days
Time frame: Day 1 to Day 28
Time to sustained resolution of each targeted COVID-19 symptom
Time frame: Day 1 to Day 28
Change of the score of each COVID-19 symptom
Time frame: Day 1 to Day 28
Proportion of severe cases within 28 days
Time frame: Day 1 to Day 28
The plasma concentration of HS-10517 in COVID-19 patients in phase II study
Time frame: Day 1 to Day 7
Population apparent clearance (CL/F) of COVID-19 patients in phase II study
Time frame: Day 1 to Day 7
Population apparent volume of distribution (Vd/F) of COVID-19 patients in phase II study
Time frame: Day 1 to Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS-10517 Dose 1, HS-10517 Dose 2 and HS-10517 Dose 3 in people with COVID-19, 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 25 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linlin Song (0531-89268311, 13335126599@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in single ascending dose (SAD) (time frame: Day 1 to Day 5). The study lists 16 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 3 Apr 2023.