HealthyPhase 1NCT04652297
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
A Phase 1 study testing HS-10356 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administration of HS-10356 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HS-10356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must meet all of the following inclusion criteria to be eligible for participation in this study:
- Full understanding of the content, process and possible adverse reactions of the study, and sign the ICF voluntarily;
- Healthy Volunteers between 18 and 55 years of age (including the critical value);
- Male weight is not less than 50 kg, female weight is not less than 45 kg. The body mass index (BMI = weight (kg)/height (m2). The BMI should be controlled within the range of 18 to 26 (including the critical value);
- Volunteers agree to refrain from smoking, drinking alcohol. Avoid xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise;
- Agreed to use effective contraception from the date of signing of the ICF until six months after the last administration;
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- The male volunteers agreed to refrain from donating sperm from the start of the drug until six months after they stopped the study;
- The female volunteers agreed to avoid ovum donation from the start of the drug until six months after they stopped the study;
- Pregnancy test results of female volunteers must be negative within 3 days of administration.
Who cannot join
- Pregnant and breastfeeding female.
- Volunteers with a history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematological, metabolic and other systemic diseases, who are not suitable to participate in this study as assessed by the investigator.
- The results of vital signs, physical examination, laboratory examination and 12-lead ECG during screening were abnormal with clinical significance.
- Major surgery was performed within 3 months prior to the screening or surgery was planned during the study.
- Severe infections, such as cellulitis, pneumonia, sepsis, have occurred or are present in the 30 days prior to screening.
- ALT, AST, ALP or bilirubin were higher than the upper limit of normal.
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- Creatinine clearance < 90mL/min at screening (Cockcroft-Gault method), as follows:
- (140-age in years)×weight (kg)/72×serum creatinine（mg/dL）×(Female×0.85)；
- 8.Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb) or syphilis antibody is positive.
- 9.Volunteers had a history of drug dependence or abuse.
- 10.A heavy smoker or smokers who smoked 5 or more cigarettes per day for 3 months prior to screening or tested positive for nicotine during screening.
- 11.A history of alcohol abuse or a single consumption of more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 150 mL of wine) in the nearly two weeks prior to screening or a positive breath test for alcohol at screening.
- 12.Participate in clinical trials of any drug or medical device within 3 months prior to screening.
- 13.Blood donation or blood loss ≥ 400mL within 3 months prior to screening, or blood transfusion received; Blood donation or blood loss ≥ 200mL within 1 month before screening.
- 14.Volunteers received systemic steroid, immunomodulator, or chemotherapy in the 3 months prior to screening，or likely to be treated with these drugs such as corticosteroids, immunoglobulin, and other immune or cytokine therapy during the study period.
- 15.Gastrointestinal ulcer, gastroesophageal reflux disease, or other severe symptoms of excess gastric acid secretion.
- 16.Medical or surgical treatment that permanently alters oral drug absorption and excretion, such as Gastric or intestinal surgery. Cholecystectomy, appendectomy and hernia repair are excluded.
- 17.Potent CYP3A4 inhibitors and potent CYP3A4 inducers was used within 28 days before administration.
- 18.Any medication taken within 2 weeks of administration, including prescription, over-the-counter, and herbal medicines.
- 19.Grapefruit juice, grapefruit and Seville orange juice were consumed in the 2 weeks prior to administration.
- 20.Diet or dietary treatment or significant change in dietary habits within 30 days prior to administration for whatever reason.
- 21.Volunteers who have difficulty swallowing solid tablets or capsule. 22.Volunteers with difficulty in blood collection, unable to tolerate multiple venous blood collection and any blood collection contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xiaojian Zhang, BS, 086-0371-66913047, Zhxj0524@sina.com
Xin Tian, PhD, 086-0371-66295651, tianx@zzu.edu.cn
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Dose Escalation Trial to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administration of HS-10356 in healthy volunteers.
Read the detailed description
This is a phase I, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10356 oral formulation in Chinese healthy adult volunteers.
Approximately five sequential dose panels (single oral doses of 2,6,15,30,45mg HS-10356) will be evaluated in SAD. To protect the safety of volunteers, two sentinel volunteers were first enrolled in the first dose panel (2mg panel) and randomly assigned to HS-10356 or placebo in a 1:1 ratio. After the sentinel volunteers were given the dose for at least 24 hours and confirmed that they were safe, the remaining 6 volunteers were randomly assigned to HS-10356 or placebo in a ratio of 5:1. For the follow-up panels of SAD, volunteers were randomly assigned to either the experimental group or the placebo group (6 cases in HS-10356 and 2 cases in placebo) in a 3:1 ratio using block randomization method. Approximately three sequential dose panels (14 consecutive days for respectively daily oral doses of 6,15,30mg HS-10356, QD) will be evaluated in MAD. Volunteers were randomly assigned to either the experimental group or the placebo group (9 cases in the HS-10356 and 3 cases in the placebo) in a ratio of 3:1 using block randomization method. Each subject will receive only one regimen in this study. Safety data up to Day12 (±2) in SAD and up to Day25 (±2) in MAD will be reviewed prior to dose escalation. Cohorts of SAD and MAD will be added or removed depending on the assessment results of SRC.
- Conditions
- Healthy
- Being tested
- HS-10356, Placebo
- Keywords
- HS-10356, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10356Drug
Single dose of HS-10356
PlaceboDrug
Single dose of Placebo
HS-10356Drug
Multiple doses of HS-10356
PlaceboDrug
Multiple doses of Placebo
| Study group | Role | What they receive |
|---|---|---|
| HS-10356 single dose | Experimental | Single oral dose of HS-10356 ascending dose Receives: Drug: HS-10356 |
| placebo single dose | Placebo comparator | Single oral dose of placebo ascending doses Receives: Drug: Placebo |
| HS-10356 multiple doses | Experimental | Multiple oral doses of HS-10356 ascending doses Receives: Drug: HS-10356 |
| Placebo multiple doses | Placebo comparator | Multiple oral doses of placebo ascending doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence, severity, and association of AE, SAE, and adverse events leading to withdrawal from the trial
Measured: SAD: Day1~Day12
The incidence, severity, and association of AE, SAE, and adverse events leading to withdrawal from the trial
Measured: MAD: Day1~Day25
Laboratory assessment:Haematology
Measured: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Haematology
Measured: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Clinical Chemistry
Measured: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Clinical Chemistry
Measured: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Routine Urinalysis
Measured: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Routine Urinalysis
Measured: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Coagulation test
Measured: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Coagulation test
Measured: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Vital signs:Blood pressure
Measured: Within 1 hour before administration,1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Blood pressure
Measured: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Pulse rate
Measured: Within 1 hour before administration, 1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Pulse rate
Measured: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Respiratory rate
Measured: Within 1 hour before administration, 1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Respiratory rate
Measured: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Temperature
Measured: Within 1 hour before administration,1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Temperature
Measured: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14,once a day on days 15 to 19 in MAD
Physical examination:General
Measured: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:General
Measured: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Lymph node
Measured: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Lymph node
Measured: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Chest
Measured: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Chest
Measured: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Abdominal
Measured: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Abdominal
Measured: 24hours after the first and last administration, prior to discharge from hospital in MAD
12-lead electrocardiogram (ECG) parameters ( Heart rate, PR, R-R, QRS and QTcF (average))
Measured: Within 1 hour before administration,1hours, 2hours, 3hours, 24hours 120hours after administration in SAD.
Secondary outcomes (20)
SAD pharmacokinetic endpoint:The maximum plasma concentration (Cmax)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Time to Cmax (Tmax)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-∞)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Terminal rate constant (λz)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Half life (t½)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Apparent clearance following extravascular administration (CL/F)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Apparent volume of distribution following extravascular administration (Vd/F)
Measured: Day1-Day6
SAD pharmacokinetic endpoint:Mean residence time (MRT)
Measured: Day1-Day6
MAD pharmacokinetic endpoint:The maximum steady state drug concentration in plasma during dosing interval (Css,max)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:The minimum steady state drug concentration in plasma during dosing interval (Css,min)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Average steady state drug concentration in plasma during dosing interval (Css,av)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Time to Css, max (Tss,max)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve over the dosing interval at steady state (AUCss)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration at steady state(AUC0-t)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-∞) at steady state
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Half life (t½)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Accumulation ratio (Rac)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Apparent clearance at steady state following extravascular administration (CLss/F)
Measured: Day1-Day19
MAD pharmacokinetic endpoint:Apparent volume of distribution at steady state following extravascular administration (Vd/F)
Measured: Day1-Day19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 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
- NCT04652297
- Sponsor's protocol ID
- HS-10356-101
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Dose Escalation Trial to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04652297
- Acronym / sponsor ID
- HS-10356-101
- Conditions
- Healthy
- Keywords
- HS-10356, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 Dec 2020 (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.
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administration of HS-10356 in healthy volunteers.
Detailed description
This is a phase I, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10356 oral formulation in Chinese healthy adult volunteers.
Approximately five sequential dose panels (single oral doses of 2,6,15,30,45mg HS-10356) will be evaluated in SAD. To protect the safety of volunteers, two sentinel volunteers were first enrolled in the first dose panel (2mg panel) and randomly assigned to HS-10356 or placebo in a 1:1 ratio. After the sentinel volunteers were given the dose for at least 24 hours and confirmed that they were safe, the remaining 6 volunteers were randomly assigned to HS-10356 or placebo in a ratio of 5:1. For the follow-up panels of SAD, volunteers were randomly assigned to either the experimental group or the placebo group (6 cases in HS-10356 and 2 cases in placebo) in a 3:1 ratio using block randomization method. Approximately three sequential dose panels (14 consecutive days for respectively daily oral doses of 6,15,30mg HS-10356, QD) will be evaluated in MAD. Volunteers were randomly assigned to either the experimental group or the placebo group (9 cases in the HS-10356 and 3 cases in the placebo) in a ratio of 3:1 using block randomization method. Each subject will receive only one regimen in this study. Safety data up to Day12 (±2) in SAD and up to Day25 (±2) in MAD will be reviewed prior to dose escalation. Cohorts of SAD and MAD will be added or removed depending on the assessment results of SRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-10356 single dose | Experimental | Drug: HS-10356Single oral dose of HS-10356 ascending dose |
| placebo single dose | Placebo comparator | Drug: PlaceboSingle oral dose of placebo ascending doses |
| HS-10356 multiple doses | Experimental | Drug: HS-10356Multiple oral doses of HS-10356 ascending doses |
| Placebo multiple doses | Placebo comparator | Drug: PlaceboMultiple oral doses of placebo ascending doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteers must meet all of the following inclusion criteria to be eligible for participation in this study:
- Full understanding of the content, process and possible adverse reactions of the study, and sign the ICF voluntarily;
- Healthy Volunteers between 18 and 55 years of age (including the critical value);
- Male weight is not less than 50 kg, female weight is not less than 45 kg. The body mass index (BMI = weight (kg)/height (m2). The BMI should be controlled within the range of 18 to 26 (including the critical value);
- Volunteers agree to refrain from smoking, drinking alcohol. Avoid xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise;
Key exclusion criteria (22 listed)
- Pregnant and breastfeeding female.
- Volunteers with a history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematological, metabolic and other systemic diseases, who are not suitable to participate in this study as assessed by the investigator.
- The results of vital signs, physical examination, laboratory examination and 12-lead ECG during screening were abnormal with clinical significance.
- Major surgery was performed within 3 months prior to the screening or surgery was planned during the study.
- Severe infections, such as cellulitis, pneumonia, sepsis, have occurred or are present in the 30 days prior to screening.
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-10356Single dose of HS-10356 | Drug | HS-10356 single dose |
| PlaceboSingle dose of Placebo | Drug | placebo single dose |
| HS-10356Multiple doses of HS-10356 | Drug | HS-10356 multiple doses |
| PlaceboMultiple doses of Placebo | Drug | Placebo multiple doses |
Primary outcome
The incidence, severity, and association of AE, SAE, and adverse events leading to withdrawal from the trial
Time frame: SAD: Day1~Day12
The incidence, severity, and association of AE, SAE, and adverse events leading to withdrawal from the trial
Time frame: MAD: Day1~Day25
Laboratory assessment:Haematology
Time frame: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Haematology
Time frame: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Clinical Chemistry
Time frame: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Clinical Chemistry
Time frame: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Routine Urinalysis
Time frame: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Routine Urinalysis
Time frame: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Laboratory assessment:Coagulation test
Time frame: Predose, day 6 prior to discharge from hospital in SAD.
Laboratory assessment:Coagulation test
Time frame: Predose, day4、day7、day10、day14、day19 prior to discharge from hospital in MAD
Vital signs:Blood pressure
Time frame: Within 1 hour before administration,1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Blood pressure
Time frame: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Pulse rate
Time frame: Within 1 hour before administration, 1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Pulse rate
Time frame: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Respiratory rate
Time frame: Within 1 hour before administration, 1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Respiratory rate
Time frame: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14, once a day on days 15 to 19 in MAD
Vital signs:Temperature
Time frame: Within 1 hour before administration,1hour, 2hours, 4hours, 12hours, 24hours, 48hours, 72hours, 96hours, and 120hours after administration in SAD.
Vital signs:Temperature
Time frame: Within 1 hour before administration, 1hours, 2hours, 4hours, 12hours on days 1,2,4,6,8,10,12 and 14,once a day on days 15 to 19 in MAD
Physical examination:General
Time frame: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:General
Time frame: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Lymph node
Time frame: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Lymph node
Time frame: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Chest
Time frame: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Chest
Time frame: 24hours after the first and last administration, prior to discharge from hospital in MAD
Physical examination:Abdominal
Time frame: 2hours, 24hours and 120hours after administration in SAD.
Physical examination:Abdominal
Time frame: 24hours after the first and last administration, prior to discharge from hospital in MAD
12-lead electrocardiogram (ECG) parameters ( Heart rate, PR, R-R, QRS and QTcF (average))
Time frame: Within 1 hour before administration,1hours, 2hours, 3hours, 24hours 120hours after administration in SAD.
20 secondary outcomes
SAD pharmacokinetic endpoint:The maximum plasma concentration (Cmax)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Time to Cmax (Tmax)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-∞)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Terminal rate constant (λz)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Half life (t½)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Apparent clearance following extravascular administration (CL/F)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Apparent volume of distribution following extravascular administration (Vd/F)
Time frame: Day1-Day6
SAD pharmacokinetic endpoint:Mean residence time (MRT)
Time frame: Day1-Day6
MAD pharmacokinetic endpoint:The maximum steady state drug concentration in plasma during dosing interval (Css,max)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:The minimum steady state drug concentration in plasma during dosing interval (Css,min)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Average steady state drug concentration in plasma during dosing interval (Css,av)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Time to Css, max (Tss,max)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve over the dosing interval at steady state (AUCss)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration at steady state(AUC0-t)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:The area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-∞) at steady state
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Half life (t½)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Accumulation ratio (Rac)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Apparent clearance at steady state following extravascular administration (CLss/F)
Time frame: Day1-Day19
MAD pharmacokinetic endpoint:Apparent volume of distribution at steady state following extravascular administration (Vd/F)
Time frame: Day1-Day19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
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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 study testing HS-10356 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 9 inclusion and 22 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 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian Zhang, BS (086-0371-66913047, Zhxj0524@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence, severity, and association of AE, SAE, and adverse events leading to withdrawal from the trial (time frame: SAD: Day1~Day12). The study lists 27 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 Dec 2020.