A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)

NCT07579949 | Not Yet Recruiting Phase 2

• 1 other identifier: SNH-119014-II-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (1)

• Safety evaluation

  The incidence of Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events

  From signing the informed consent to 4 weeks after the last dose

Study Arms (3)

Cohort 1

EXPERIMENTAL

Study Drug

Drug: SNH-119014 dose 1

Cohort 2

EXPERIMENTAL

Study Drug

Drug: SNH-119014 dose 2

Cohort 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SNH-119014 dose 1 DRUG

Study Drug

Cohort 1

SNH-119014 dose 2 DRUG

Study Drug

Cohort 2

Placebo DRUG

Placebo

Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Foshan First People's Hospital

Foshan, Guangdong, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Maoming People's Hospital

Maoming, Guangdong, China

Location

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Location

923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of China

Nanning, Guangxi, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The First Affiliated Hospital of Hainan Medical University

Haikou, Hunan, China

Location

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yongrong Lai, Ph.D

CONTACT

0771-6356510; laiyongrong@263.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): April 29, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (8)