To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects

NCT06543459 | Not Yet Recruiting Phase 1

• 1 other identifier: MY008211-1-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (1)

• ΔΔQTcF (Using Fridericia Formula as the Primary Method for QT Interval Correction)

  Placebo-corrected, baseline-adjusted QTc interval of prodrug and active metabolite (if necessary)

  up to 2 weeks

Secondary Outcomes (9)

• Cmax (Maximum plasma concentration)

  up to 2 weeks

• Tmax (Time to maximum plasma concentration)

  up to 2 weeks

• t1/2 (Terminal elimination half-life time)

  up to 2 weeks

• AUC0-t (Area under the plasma concentration-time curve from time 0 to the collection time t with the last measurable plasma concentration)

  up to 2 weeks

• AUC0-∞ (Area under the plasma concentration-time curve extrapolated from time 0 to infinity)

  up to 2 weeks

Study Arms (4)

Group A, Sequence 1, Dose 1

EXPERIMENTAL

Participants randomized to receive MY008211A tablets or placebo on Day 1.

Drug: MY008211A tablets

Group A, Sequence 2, Dose 2

EXPERIMENTAL

Participants randomized to receive MY008211A tablets or placebo on Day 7.

Drug: MY008211A tablets

Group B, Sequence 1, Dose 1

PLACEBO COMPARATOR

Participants randomized to receive MY008211A tablets or placebo on Day 1.

Drug: Placebo

Group B, Sequence 2, Dose 2

PLACEBO COMPARATOR

Participants randomized to receive MY008211A tablets or placebo on Day 7.

Drug: Placebo

Interventions

MY008211A tablets DRUG

Subjects of Group A receive MY008211A tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.

Group A, Sequence 1, Dose 1; Group A, Sequence 2, Dose 2

Placebo DRUG

Subjects of Group A receive placebo tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.

Group B, Sequence 1, Dose 1; Group B, Sequence 2, Dose 2

Eligibility Criteria

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

You may qualify if:

• Volunteers must be fully informed of this study and the content, process of the study and possible adverse events related to experimental drug will be fully understood, and voluntarily signed a written Informed Consent Form (ICF);
• ≤ age ≤ 45 years old, male or female Chinese adult volunteers;
• Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m2 (inclusive) at screening;
• Volunteers should be able to communicate well with the investigator, understand and comply with the requirements of the study.

You may not qualify if:

• The investigator judges that there are other disease or medical conditions that are clinical significant or may prevent the volunteer from following the study protocol and completing the study, abnormal including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, immune system, mental system, endocrine and metabolic system;
• Volunteers with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and judged by the investigator to have clinical significance at present;
• Volunteers with hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia or hypocalcemia and judged by the investigator to have clinical significance;
• History of known or suspected immunodeficiency (e.g., history of frequent recurrent infections), inherited or acquired complement deficiency；
• Volunteers who underwent surgery within 6 months pre-dose, which judged by the investigator to affect the absorption, distribution, metabolism, and excretion of the experimental drug(e.g. cholecystectomy, except appendicitis surgery); Surgical procedures within 4 weeks pre-dose or planned to undergo a surgical procedure during the trial;
• Volunteers who had a clear history of capsular microbial infection within 6 months before screening; Including but not limited to: Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila infection history;
• Volunteers with previous or current history of TB infection or with positive lymphobacteria culture + interferon test；
• Active systemic bacterial, viral, or fungal infection within 14 days pre-dose;
• Fever (≥ 38 ℃) within 7 days pre-dose;
• Volunteers with a history of clinically significant drug allergy or allergic disease (such as asthma, urticaria, eczematous dermatitis, etc.), or a possible or clear allergy to the experimental drug (including similar drugs) or any excipients thereof as judged by the investigator;
• Volunteers with clinical significant examination abnormalities which judged by the investigator such as vital signs, physical examination, routine laboratory tests (can reviewable, including: blood routine, reticulocyte count, procalcitonin + myoglobin, blood biochemical + hypersensitive C-reactive protein, urine routine, coagulation function + plasma D-Dimer determination), chest X-ray, abdominal ultrasound at screening or baseline；
• Volunteers with 12-ECG examination and reviewable result such as QTcF≥450 ms or PR interval ≥200ms or QRS wave complex ≥120ms or clinical significant abnormality ECG which judged by the investigator at screening or baseline or pre-dose；
• Volunteers who administrated any other clinical study drug or enrolled in any Interventional clinical trial within 3 months before screening；
• Volunteers who donated blood or lost blood (≥ 400mL) within 3 months pre-dose, received a blood transfusion or use of blood products within 4 weeks pre-dose, or intended to donate blood or blood components during or within 3 months after study;
• Volunteers who had taken any medicine or OTC medicine or Chinese herbal medicine or food supplement (including vitamins, health foods, etc.) other non-drug therapeutic factors that affect drug absorption, distribution, metabolism and excretion;

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Officials

• Haiyan Li, PhD

  PI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuhui Hu, master

CONTACT

021-51158605; huyuhui@createrna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: August 2, 2024
• First Posted: August 9, 2024
• Study Start: August 10, 2024
• Primary Completion: September 27, 2024
• Study Completion: December 13, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)