Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects

NCT05828485 | Completed Phase 1

• 1 other identifier: MY008211-1-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2: BA). Each dosing sequence consisted of two cycles, one dose per cycle, with a 5-day washout period between doses.

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  Maximum Plasma Concentration (Cmax) Of MY008211A tablets

  up to 72 hours postdose

• The Maximum Plasma Concentration (Tmax)

  Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A

  up to 72 hours postdose

• Area Under The Concentration Versus Time Curve (AUC)

  Area Under The Concentration Versus Time Curve (AUC) Of MY008211A

  up to 72 hours postdose

Secondary Outcomes (1)

• The incidence and severity of adverse events to assess safety and tolerability

  up to 9 days

Study Arms (2)

Sequence 1 : AB

EXPERIMENTAL

6 subjects were given a single dose of MY008211A tablets in the fasting state and, after a 5-day washout period, a single dose of MY008211A tablet was administered after taking a standard high-fat and high-calorie fed.

Drug: MY008211A tablets

Sequence 1 : BA

EXPERIMENTAL

6 subjects were given a single dose of MY008211A tablet after taking a standard high-fat and high-calorie fed and, after a 5-day washout period, a single dose of MY008211A tablet in the fasting state.

Drug: MY008211A tablets

Interventions

MY008211A tablets DRUG

A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding

Also known as: no other name

Sequence 1 : AB; Sequence 1 : BA

Eligibility Criteria

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

You may qualify if:

• ≤ 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;
• The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

You may not qualify if:

• 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;
• Patients who underwent surgery within 6 months before the study drug is used, which will be judged by the investigators to affect the absorption, distribution, metabolism, and excretion of the study drug; Surgical procedures within 4 weeks before the use of the study drug; Or planned to undergo a surgical procedure during the trial;
• Who had taken any medicine (including Chinese herbal medicine, health products, etc.) within 14 days before administration of the study drug;
• Who received a vaccine or live attenuated vaccine within 14 days before administration of the study drug, or who plan to receive a vaccine during the trial;
• Who donated blood or lost a large amount of blood (\> 400mL) within 3 months before administration of the study drug, received a blood transfusion or use of blood products, or intended to donate blood or blood components during or within 3 months after administration of the study drug;
• Drug abusers or had used hard drugs (e.g., cocaine, phencyhexidine, etc.) or soft drugs (e.g., cannabis) within 1 year before administration of the study drug;

Sponsors & Collaborators

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

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410011, 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

• Wei feng, Ph.D

  Wuhan Createrna Science and Technology Co., Ltd

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 25, 2023
• Study Start: September 26, 2022
• Primary Completion: October 23, 2022
• Study Completion: October 23, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)