ThalassemiaPhase 2NCT07579949
A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)
A Phase 2 study testing SNH-119014 dose 1 and SNH-119014 dose 2 in people with Thalassemia, run by ScinnoHub Pharmaceutical Co., Ltd. at 8 sites in China.
Trial summary
This study is a multicenter study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of treatment with SNH-119014 in adult participants with non-transfusion-dependent thalassemia. 30 participants with non-transfusion-dependent thalassemia were enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thalassemia
- What is being tested?
- SNH-119014 dose 1 and SNH-119014 dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 8 sitesChina
- Study dates
- 18 Jun 2026to 29 Apr 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female;
- -≥18 years;
- Documented diagnosis of thalassemia;
- Non-transfusion-dependent;
- Hb concentration ≤10.0 grams per deciliter (g/dL) during the screening period;
- For women of reproductive potential: negative serum pregnancy test during the screening period;
- Agreement to use approved contraceptive measures;
- Informed consent;
Who cannot join
- Hemoglobin S forms of thalassemia;
- History of Congestive Heart Failure Within 6 months prior to signed informed consent;
- Myocardial Infarction/unstable angina Within 6 months prior to signed informed consent;
- Deep Vein Thrombosis/stroke/thromboembolic events Within 6 months prior to signed informed consent;
- Poorly controlled hypertension or diabetes;
- Markedly abnormal QTcF interval;
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- Severe arrhythmia requiring treatment as assessed by the investigator;
- Markedly abnormal left ventricular ejection fraction;
- Diagnosis of any other congenital or acquired hematologic disorder, or any other hemolytic process;
- Active infection requiring intravenous antibiotics or of Grade ≥3 severity within 4 weeks prior to the first dose;
- History of primary malignancy, except for: cured non-melanoma skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumors treated with curative intent with no known active disease and no treatment in the past 5 years;
- History of neurological or psychiatric disorders that, in the investigator's assessment, may affect the participant's ability to participate in the clinical study;
- Post-splenectomy sepsis;
- Severe pulmonary disease or hepatobiliary disease;
- Abnormal laboratory tests during screening;
- Use of luspatercept, hydroxyurea, erythropoietin, strong CYP3A4 inhibitors, or strong CYP3A4 inducers within the prohibited period specified in the protocol;
- Receipt of anticoagulant therapy prior to screening, or requirement for anticoagulant therapy during the study period;
- Prior bone marrow or stem cell transplant;
- Pregnant or lactating women;
- Major surgery within 6 months prior to signing informed consent or planned during the study period;
- Splenectomy scheduled during the study treatment period;
- Participation in another clinical trial and receipt of investigational treatment within 3 months;
- History of severe allergy, or allergy to SNH-119014 or its excipients;
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan
Xiaobing Huang, 18981838236, huangxiaobing@med.uestc.edu.cn
Foshan First People's Hospital
Foshan, Guangdong
Yonglei Qi, 18038865128, qylei12@fsyyy.com
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Ling Jiang, 18620109403, jlapple@126.com
The First Affiliated Hospital of Hainan Medical University
Haikou, Hunan
Lu Xu, 13518073033, xulu2324@163.com
Liuzhou People's Hospital
Liuzhou, Guangxi
Liuting Lu, 13558224507, 289761556@qq.com
Maoming People's Hospital
Maoming, Guangdong
Ying Dong, 13432321706, 997281241@qq.com
923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Nanning, Guangxi
Yali Zhou, 13507883961, 252749070@qq.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Yongrong Lai, Ph.D, 0771-6356510, laiyongrong@263.net
About this study
Official title: A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia
This study is a multicenter study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of treatment with SNH-119014 in adult participants with non-transfusion-dependent thalassemia. 30 participants with non-transfusion-dependent thalassemia were enrolled.
- Conditions
- Thalassemia
- Being tested
- SNH-119014 dose 1, SNH-119014 dose 2, Placebo
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNH-119014 dose 1Drug
Study Drug
SNH-119014 dose 2Drug
Study Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Study Drug Receives: Drug: SNH-119014 dose 1 |
| Cohort 2 | Experimental | Study Drug Receives: Drug: SNH-119014 dose 2 |
| Cohort 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
The incidence of Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events
Measured: From signing the informed consent to 4 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start18 Jun 2026 (estimated)
- Primary completion29 Mar 2027 (estimated)
- Study completion29 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT07579949
- Sponsor's protocol ID
- SNH-119014-II-01
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia
- ClinicalTrials.gov ID
- NCT07579949
- Acronym / sponsor ID
- SNH-119014-II-01
- Conditions
- Thalassemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 29 Apr 2027 (estimated)
- First posted
- 12 May 2026 (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.
This study is a multicenter study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of treatment with SNH-119014 in adult participants with non-transfusion-dependent thalassemia. 30 participants with non-transfusion-dependent thalassemia were enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SNH-119014 dose 1Study Drug |
| Cohort 2 | Experimental | Drug: SNH-119014 dose 2Study Drug |
| Cohort 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female;
- -≥18 years;
- Documented diagnosis of thalassemia;
- Non-transfusion-dependent;
- Hb concentration ≤10.0 grams per deciliter (g/dL) during the screening period;
Key exclusion criteria (24 listed)
- Hemoglobin S forms of thalassemia;
- History of Congestive Heart Failure Within 6 months prior to signed informed consent;
- Myocardial Infarction/unstable angina Within 6 months prior to signed informed consent;
- Deep Vein Thrombosis/stroke/thromboembolic events Within 6 months prior to signed informed consent;
- Poorly controlled hypertension or diabetes;
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-119014 dose 1Study Drug | Drug | Cohort 1 |
| SNH-119014 dose 2Study Drug | Drug | Cohort 2 |
| PlaceboPlacebo | Drug | Cohort 3 |
Primary outcome
Safety evaluation
Time frame: From signing the informed consent to 4 weeks after the last dose
The incidence of Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events
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 12 May 2026.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNH-119014 dose 1 and SNH-119014 dose 2 in people with Thalassemia, run by ScinnoHub Pharmaceutical Co., Ltd. at 8 sites 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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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?
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 Yongrong Lai, Ph.D (0771-6356510, laiyongrong@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: From signing the informed consent to 4 weeks after the last dose). 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 12 May 2026.