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CompletedNCT05828485Updated Apr 25, 2023

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

A Phase 1 interventional study of MY008211A tablets in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Wuhan Createrna Science and Technology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Wuhan Createrna Science and Technology Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2022, registered Apr 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

A: A single dose of MY008211A tablets was administered in the fasting state (fasting for at least 10 h with water as needed).

B: A single dose of MY008211A tablets was administered after a standard high-fat, high-calorie fed.

02

Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
03

In context

Hemoglobinuria, Paroxysmal

192 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.

This study's enrollment of 12 is below the median of 34 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.

Browse Hemoglobinuria, Paroxysmal studies →

Lead sponsor

Wuhan Createrna Science and Technology Co., Ltd is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18≤ age ≤ 45, male or female;
  2. Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m2 (inclusive);
  3. Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
  4. The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
  2. 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;
  3. 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);
  4. History of known or suspected immunodeficiency (e.g., history of frequent recurrent infections), inherited or acquired complement deficiency;
  5. 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;
  6. Patients with previous or current history of TB infection;
  7. Active systemic bacterial, viral, or fungal infection within 14 days before administration of the study drug;
  8. Fever (≥ 38 ° C) within 7 days before administration of the study drug;
  9. 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;
  10. Those who cannot tolerate intravenous puncture or have a history of syncope or needle sickness;
  11. 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;
  12. Who had taken any medicine (including Chinese herbal medicine, health products, etc.) within 14 days before administration of the study drug;
  13. 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;
  14. 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;
  15. 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;
  16. Smokers or had smoked more than 5 cigarettes per day in 3 months before study drug use, or will be unable to stop using any tobacco products during the study;
  17. Heavy drinkers, who drink at least twice a day or more than 14 times a week, or are avid binge drinkers (one drink is defined as 125mL of wine, 220mL of beer, or 50mL of liquor; Binge drinking is defined as 5 or more drinks in approximately 2 hours); Or unwillingness to stop drinking alcohol or any alcohol-based product during the trial;
  18. Those who have special requirements for diet and cannot abide by the uniform diet;
  19. Volunteers (or their partners) who plan to be pregnant or donate sperm or eggs during the trial to 3 months after the end of the trial, or who are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, surgical sterilization, etc.);
  20. Pregnant or lactating women; Or having unprotected sex within 2 weeks before using the study drug; Or oral contraceptive use within 30 days or long-acting estrogen or progestin injectable or implant use within 6 months before use of the study drug;
  21. Physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, vital signs, laboratory examination abnormalities were clinically significant (subject to clinician's judgment);
  22. With positive uremic screening test;
  23. With positive alcohol breath test;
  24. Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Sequence 1 : AB

    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

  • Experimental
    Sequence 1 : BA

    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

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

    Also known as: no other name

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Maximum Plasma Concentration (Cmax) Of MY008211A tablets

    Time frame: up to 72 hours postdose

  2. The Maximum Plasma Concentration (Tmax)

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

    Time frame: up to 72 hours postdose

  3. Area Under The Concentration Versus Time Curve (AUC)

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

    Time frame: up to 72 hours postdose

Secondary outcomes

  1. The incidence and severity of adverse events to assess safety and tolerability

    such as laboratory abnormalities

    Time frame: up to 9 days

07

Study locations

1 site
  • The Third Hospital of Changsha
    Changsha, Hunan 410011, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Oct 2022, 0 months.

Of 17 phase 1 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2023
First posted
Apr 25, 2023
StartActual
Sep 26, 2022
Primary completionActual
Oct 23, 2022
CompletionActual
Oct 23, 2022
Last update
Apr 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05828485
Lead sponsor
Wuhan Createrna Science and Technology Co., Ltd
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
Sep 26, 2022
Primary completion
Oct 23, 2022
Completion
Oct 23, 2022
Last update
Apr 25, 2023

Study contacts

Wei feng, Ph.D
study chair · Wuhan Createrna Science and Technology Co., Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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