HealthyPhase 1NCT05953506
Phase 1a Study in Healthy Participants
A Phase 1 study testing HS-10506 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HS-10506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2023to 24 Dec 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged from 18 to 45 years
- Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
- Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18~28 (including the critical value)
- During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception
Who cannot join
- Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
- Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
- Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), >450 ms (males), >470 ms (females)
- Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.
Read the detailed description
This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.
- Conditions
- Healthy
- Being tested
- HS-10506, HS-10506 Placebo
- Keywords
- HS-10506, Phase 1, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10506Drug
HS-10506 will be administered orally once on Day 1.
HS-10506 PlaceboDrug
Matching placebo will be administered orally once on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| HS-10506 | Experimental | Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. Receives: Drug: HS-10506 |
| HS-10506 Placebo | Experimental | Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. Receives: Drug: HS-10506 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), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug
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: Screening until Trail phase (up to 5 weeks)
Number of participants with clinically significant change from baseline in vital signs
Measured: From baseline to Day 3
Number of participants with clinically significant abnormalities in physical examination
Measured: From baseline to Day 3
Changes in 12-lead electrocardiogram from before to after dosing
Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Measured: From baseline to Day 3
Change in Stanford Sleepiness Scale score from before to after dosing
Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point.
Measured: From baseline to 4 hours after dosing
Secondary outcomes (9)
Observed maximum plasma concentration (Cmax)
Cmax will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Time to reach maximum plasma concentration (Tmax)
Tmax will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Area under the concentration-time curve from time zero to infinity（AUC0-∞）
AUC0-t will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Terminal Rate Constant（λz）
Terminal Rate Constant（λz） will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Elimination Halflife (T1/2)
Elimination Halflife (T1/2) is the time measured for the concentration to decrease by one half，which will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Apparent clearance（CL/F）
CL/F will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 hours after dosing
Apparent Volume of Distribution（Vd/F）
Vd/F will be obtained following administration of a single oral dose of HS-10506.
Time Frame: up to 48 hours after dosing
Measured: up to 48 hours after dosing
Mean Residence Time(MRT)
RT will be obtained following administration of a single oral dose of HS-10506.
Measured: up to 48 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 posted20 Jul 2023
- Study start17 Jul 2023 (estimated)
- Primary completion24 Dec 2023 (estimated)
- Study completion24 Dec 2023 (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, Care provider
- Enrolment
- 52 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
- NCT05953506
- Sponsor's protocol ID
- HS-10506-101
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05953506
- Acronym / sponsor ID
- HS-10506-101
- Conditions
- Healthy
- Keywords
- HS-10506, Phase 1, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (estimated)
- Primary completion
- 24 Dec 2023 (estimated)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 20 Jul 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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.
Detailed description
This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10506 | Experimental | Drug: HS-10506Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. |
| HS-10506 Placebo | Experimental | Drug: HS-10506 PlaceboHealthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy participants aged from 18 to 45 years
- Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
- Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18~28 (including the critical value)
- During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception
Key exclusion criteria (4 listed)
- Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
- Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
- Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), >450 ms (males), >470 ms (females)
- Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm
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-10506HS-10506 will be administered orally once on Day 1. | Drug | HS-10506 |
| HS-10506 PlaceboMatching placebo will be administered orally once on Day 1. | Drug | HS-10506 Placebo |
Primary outcome
Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug
Time frame: Screening until Trail phase (up to 5 weeks)
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
Time frame: From baseline to Day 3
Number of participants with clinically significant abnormalities in physical examination
Time frame: From baseline to Day 3
Changes in 12-lead electrocardiogram from before to after dosing
Time frame: From baseline to Day 3
Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Change in Stanford Sleepiness Scale score from before to after dosing
Time frame: From baseline to 4 hours after dosing
Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point.
9 secondary outcomes
Observed maximum plasma concentration (Cmax)
Time frame: up to 48 hours after dosing
Time to reach maximum plasma concentration (Tmax)
Time frame: up to 48 hours after dosing
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）
Time frame: up to 48 hours after dosing
Area under the concentration-time curve from time zero to infinity（AUC0-∞）
Time frame: up to 48 hours after dosing
Terminal Rate Constant（λz）
Time frame: up to 48 hours after dosing
Elimination Halflife (T1/2)
Time frame: up to 48 hours after dosing
Apparent clearance（CL/F）
Time frame: up to 48 hours after dosing
Apparent Volume of Distribution（Vd/F）
Time frame: up to 48 hours after dosing
Mean Residence Time(MRT)
Time frame: up to 48 hours after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10506 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li (021-34773128, lhlh_5@163.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), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug (time frame: Screening until Trail phase (up to 5 weeks)). The study lists 5 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 20 Jul 2023.