A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Doses Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MY008211A Tablets in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- MY008211A tablets matched placebo
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The incidence and severity of adverse events to assess safety and tolerability
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation, and multiple-dose study to evaluate safety, tolerability, PK and PD of MY008211A Tablets in healthy subjects.
Detailed Description
MY008211A Tablets, low/moderate/high dose orally, continually 7 days
Investigators
Eligibility Criteria
Inclusion Criteria
- •18≤ age ≤ 45, male or female;
- •Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m2 (inclusive);
- •Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
- •ACYW135 meningococcal vaccine, pneumococcal vaccine were voluntarily administered at least 2 weeks before MY008211A tablet administration
- •The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion Criteria
- •Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
- •Patients 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 still clinically relevant according to the investigator;
- •Patients with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
- •History of known or suspected immunodeficiency (e.g., history of frequent recurrent infections), inherited or acquired complement deficiency;
- •Patients 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;
- •Patients with previous or current history of TB infection;
- •Active systemic bacterial, viral, or fungal infection within 14 days before administration of the study drug;
- •Fever (≥ 38 ° C) within 7 days before administration of the study drug;
- •Those who have a history of allergy to the trial preparation and any of its components or related preparations, or to drugs, foods or other substances;
- •Those who cannot tolerate intravenous puncture or have a history of syncope or needle sickness;
Arms & Interventions
Group 1：Dose1
8 subjects received Dose 1 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets matched placebo
Group 1：Dose1
8 subjects received Dose 1 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets
Group 2：Dose2
8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets
Group 2：Dose2
8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets matched placebo
Group 3：Dose3
8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets
Group 3：Dose3
8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets matched placebo
Group 4: Dose4
8 subjects received Dose 4 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets
Group 4: Dose4
8 subjects received Dose 4 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days
Intervention: MY008211A tablets matched placebo
Outcomes
Primary Outcomes
The incidence and severity of adverse events to assess safety and tolerability
Time Frame: up to 31 days
such as laboratory abnormalities
Secondary Outcomes
- Half Life (t1/2) Of MY008211A(up to 10 days)
- Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A(up to 10 days)
- Area Under The Concentration Versus Time Curve (AUC) Of MY008211A(up to 10 days)
- Maximum Plasma Concentration (Cmax) Of MY008211A tablets(up to 10 days)