A Phase I Study of SNH-119014 in Healthy Volunteers

NCT07087262 | Recruiting Phase 1

• 1 other identifier: SNH-119014-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 7 days or 20 days

Study Arms (2)

SNH-119014

EXPERIMENTAL

Drug: SNH-119014

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SNH-119014 DRUG

study drug

SNH-119014

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

MeSH Terms

Conditions

Hemoglobinopathies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Hu, Ph.D

CONTACT

86010-3856086475; huwei@ahmu.edu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 25, 2025
• Study Start: June 27, 2025
• Primary Completion: March 28, 2026
• Study Completion: March 28, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)