Paroxysmal Nocturnal HemoglobinuriaPhase 1NCT05828485
Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects
A Phase 1 study testing MY008211A tablets in people with Paroxysmal Nocturnal Hemoglobinuria, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria
- What is being tested?
- MY008211A tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2022to 23 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Who cannot join
- 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;
Show all 24Show fewer
- 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;
- 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;
- 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;
- Those who have special requirements for diet and cannot abide by the uniform diet;
- 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.);
- 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;
- Physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, vital signs, laboratory examination abnormalities were clinically significant (subject to clinician's judgment);
- With positive uremic screening test;
- With positive alcohol breath test;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Open-label Clinical Study to Evaluate the Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects
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.
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Being tested
- MY008211A tablets
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY008211A tabletsDrug
Also called no other name
A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: MY008211A tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) Of MY008211A tablets
Measured: up to 72 hours postdose
The Maximum Plasma Concentration (Tmax)
Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A
Measured: up to 72 hours postdose
Area Under The Concentration Versus Time Curve (AUC)
Area Under The Concentration Versus Time Curve (AUC) Of MY008211A
Measured: up to 72 hours postdose
Secondary outcomes (1)
The incidence and severity of adverse events to assess safety and tolerability
such as laboratory abnormalities
Measured: up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start26 Sep 2022
- Primary completion23 Oct 2022
- Study completion23 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Nocturnal HemoglobinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei feng, Ph.D, Study chair, Wuhan Createrna Science and Technology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828485
- Sponsor's protocol ID
- MY008211-1-03
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label Clinical Study to Evaluate the Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05828485
- Acronym / sponsor ID
- MY008211-1-03
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 23 Oct 2022 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 : AB | Experimental | Drug: MY008211A tablets6 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. |
| Sequence 1 : BA | Experimental | Drug: MY008211A tablets6 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
- The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY008211A tabletsAlso: no other nameA single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding | Drug | Sequence 1 : AB, Sequence 1 : BA |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: up to 72 hours postdose
Maximum Plasma Concentration (Cmax) Of MY008211A tablets
The Maximum Plasma Concentration (Tmax)
Time frame: up to 72 hours postdose
Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A
Area Under The Concentration Versus Time Curve (AUC)
Time frame: up to 72 hours postdose
Area Under The Concentration Versus Time Curve (AUC) Of MY008211A
1 secondary outcome
The incidence and severity of adverse events to assess safety and tolerability
Time frame: up to 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei feng, Ph.D study chair
Wuhan Createrna Science and Technology Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MY008211A tablets in people with Paroxysmal Nocturnal Hemoglobinuria, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: up to 72 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.