IgA NephropathyPhase 1NCT05942625
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
A Phase 1 study testing HS-10390 tablet in people with IgA Nephropathy and Focal Segmental Glomerulosclerosis, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in 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
- IgA Nephropathy, Focal Segmental Glomerulosclerosis
- What is being tested?
- HS-10390 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to 30 Dec 2024
- 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 male or female subjects between the ages of 18-45 years
- Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
- Have signed the informed consent form approved by the IRB
Who cannot join
- History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
- Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
- Have a history of or current allergic disease
- Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
- Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
- Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
- Pregnant or breastfeeding female subjects
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu
Ren Zhou, 025-83272015, zdll2015@163.com
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
- Being tested
- HS-10390 tablet, Placebo tablet
- Keywords
- HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10390 tabletDrug
Oral administration of specified dose of HS-10390
Placebo tabletDrug
Oral administration of matching dose ofplacebo
| Study group | Role | What they receive |
|---|---|---|
| HS-10390 | Experimental | Single or multiple dosing of HS-10390 in a fastingstate Receives: Drug: HS-10390 tablet |
| Placebo | Experimental | Single or multiple dosing of placebo in a fastingstate Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Secondary outcomes (7)
Maximum plasma concentration (Cmax)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Time to reach Cmax (Tmax)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Half time (t½)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent clearance (CL/F)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent volume of distribution (Vz/F)
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Accumulation ratio（Rac）
Measured: Day 14 up to Day 19 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start23 May 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942625
- Sponsor's protocol ID
- HS-10390-101
- Status last verified
- Oct 2024
- First submitted
- 4 Jul 2023
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05942625
- Acronym / sponsor ID
- HS-10390-101
- Keywords
- HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 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.
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10390 | Experimental | Drug: HS-10390 tabletSingle or multiple dosing of HS-10390 in a fastingstate |
| Placebo | Experimental | Drug: Placebo tabletSingle or multiple dosing of placebo in a fastingstate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects between the ages of 18-45 years
- Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
- Have signed the informed consent form approved by the IRB
Key exclusion criteria (7 listed)
- History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
- Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
- Have a history of or current allergic disease
- Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
- Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
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-10390 tabletOral administration of specified dose of HS-10390 | Drug | HS-10390 |
| Placebo tabletOral administration of matching dose ofplacebo | Drug | Placebo |
Primary outcome
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
7 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Time to reach Cmax (Tmax)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Half time (t½)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent clearance (CL/F)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent volume of distribution (Vz/F)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Accumulation ratio（Rac）
Time frame: Day 14 up to Day 19 (MAD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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-10390 tablet in people with IgA Nephropathy and Focal Segmental Glomerulosclerosis, run by Hansoh BioMedical R&D Company 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 3 inclusion and 7 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bicheng Liu (18001580838, liubc64@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)). 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 9 Oct 2024.