HemoglobinopathyPhase 1NCT07087262
A Phase I Study of SNH-119014 in Healthy Volunteers
A Phase 1 study testing SNH-119014 in people with Hemoglobinopathy, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemoglobinopathy
- What is being tested?
- SNH-119014
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2025to 28 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects;
- 18-45 years of age, inclusive;
- Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
- Must provide written informed consent.
Who cannot join
- History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as judged by the investigator；
- Subjects who have undergone major surgery 6 months prior to screening or who plan to undergo surgery during the study period;
- Clinically significant abnormal physical examination, vital signs, chest X-ray, laboratory tests during the screening period as judged by the investigator;
- Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalities during the screening period as judged by the investigator;
- Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody at screening;
- Subjects who have a known chronic liver disease, or who have clinically significant abnormal liver function test results during the screening period;
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- History of urinary system diseases.
- History of dysphagia or any gastrointestinal disorder affecting drug absorption.
- History of malignancy.
- History of severe allergies or allergic to the study drug or any of its components. Serious adverse reaction or hypersensitivity to any drug or the formulation excipients.
- Failure to follow a consistent diet.
- Over 5 cups (200 ml per cup) of tea, coffee, or caffeinated beverages were consumed daily during the 3 months prior to screening.
- Consumption of a specific diet (e.g. grapefruit and grapefruit-containing products, chocolate, any food containing caffeine), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before the dose of study drug.
- Subjects who have taken any drugs that alter the activity of liver enzymes and/or transporters within 28 days prior to screening.
- Females who are pregnant or lactating and subjects who are unable to use one or more nonpharmacological contraceptives.
- Subjects who have taken any prescribed or over-the-counter drug or herbal remedies or nutraceutical product within 14 days before the dose of study drug.
- Subjects who smoked more than 5 cigarettes per day during the 3 months prior to screening, or who cannot accept a smoking ban throughout the study.
- Alcohol intake >14 units per week within 6 months prior to screening (1 unit is equal to 14g of alcohol such as 360mL of beer, 45mL of 40% spirit, 150mL of wine, or a confirmed positive alcohol breath test, or alcohol prohibition is not acceptable throughout the study.
- History of drug abuse in the past 1 year prior to screening, or a confirmed positive drugs of abuse test result before randomization.
- Subjects who plan to conceive or donate sperm or eggs during the study or within 3 months after completion of study.
- Subjects has received study drug in another clinical study within 3 months before the dose of study drug.
- Subjects who have donated blood or loss ≥400 mL of blood within 3 months before the dose of study drug, or who plan to donate blood or blood components during the study or within 3 months after completion of study.
- Subjects who have received a live attenuated vaccine within 28 days before the dose of study drug.
- Subjects who cannot tolerate venipuncture, or those with a history of needle fainting or blood fainting.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Wei Hu, Ph.D, 86010-3856086475, huwei@ahmu.edu.com
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers
SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.
- Conditions
- Hemoglobinopathy
- Being tested
- SNH-119014, Placebo
- Medical subject headings
- Hemoglobinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNH-119014Drug
study drug
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| SNH-119014 | Experimental | Not described Receives: Drug: SNH-119014 |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment
Safety and Tolerability
Measured: up to 7 days or 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start27 Jun 2025
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinopathyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087262
- Sponsor's protocol ID
- SNH-119014-101
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07087262
- Acronym / sponsor ID
- SNH-119014-101
- Conditions
- Hemoglobinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNH-119014 | Experimental | Drug: SNH-119014 |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects;
- 18-45 years of age, inclusive;
- Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
- Must provide written informed consent.
Key exclusion criteria (25 listed)
- History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as judged by the investigator；
- Subjects who have undergone major surgery 6 months prior to screening or who plan to undergo surgery during the study period;
- Clinically significant abnormal physical examination, vital signs, chest X-ray, laboratory tests during the screening period as judged by the investigator;
- Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalities during the screening period as judged by the investigator;
- Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody at 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 |
|---|---|---|
| SNH-119014study drug | Drug | SNH-119014 |
| Placeboplacebo | Drug | placebo |
Primary outcome
Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment
Time frame: up to 7 days or 20 days
Safety and Tolerability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- 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.
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 SNH-119014 in people with Hemoglobinopathy, run by ScinnoHub 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 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, Ph.D (86010-3856086475, huwei@ahmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment (time frame: up to 7 days or 20 days). 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 25 Jul 2025.