A Phase I Study of SNH-119014 in Healthy Volunteers
ConditionHemoglobinopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorScinnoHub Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
SNH-119014
Drugstudy drug
Placebo
Drugplacebo
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: SNH-119014Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
up to 7 days or 20 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov