Paroxysmal Nocturnal HemoglobinuriaPhase 1NCT06543459
To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy 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
A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects 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?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 13 Dec 2024
- 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
- 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);
- 18≤ 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.
Who cannot join
- 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 torsades de pointes (TDP) or other risk factors for malignant arrhythmias, or short QT syndrome, long QT syndrome, sudden unexplained death or drowning in youth (≤ 40 years old), or a family history of a first-degree relative (i.e., biological parent, sibling, or child) of sudden infant death syndrome, or other heart disease that the investigators determined was not suitable for inclusion;
- 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;
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- 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;
- Volunteers who received a vaccine or live attenuated vaccine within 14 days pre-dose, or who plan to receive a vaccine during the study;
- Volunteers with difficulty in blood collection or cannot tolerate intravenous puncture;
- Volunteers with a history of drug use or substance abuse or with positive urine drug abuse screening test;
- Volunteers with any positive result of virological test;
- Volunteers who drink more than 14 units a week (one unit is defined as 360mL of beer or 45mL of liquor or 150mL of wine) within 3 months before screening or with positive result of alcohol breath test or unwillingness to stop drinking alcohol or any alcohol-based product during the study；
- Volunteers who smoke more than 5 cigarettes per day(or use a significant amount of nicotine products) within 3 months before screening or will be unable to stop using any tobacco products during the study or with positive result of urine nicotine test；
- Volunteers who habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages and will be unable to stop use during the study, or consume any food or drink containing chocolate, caffeine, or rich in xanthines within 48h pre-dose；
- Volunteers 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 study to 3 months after the end of the study, or who are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, surgical sterilization, etc.);
- Volunteers of pregnant or lactating women; or having unprotected sex within 2 weeks pre-dose; or oral contraceptive use within 30 days or long-acting estrogen or progestin injectable or implant use within 6 months pre-dose; or with positive blood pregnancy test pre-dose;
- Volunteers have other reasons for not fit for participating in the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100089
Haiyan Li, PhD, 010-68966677-8509 ext. 86, haiyanli1027@hotmail.com
About this study
Official title: A Single-center, Randomized, Double-blind, Single Oral Dose, Placebo-controlled Study to Evaluate the Effect of MY008211A Tablets on QTc Interval in Healthy Chinese Adult Subjects
A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects
Read the detailed description
This is a single-center, randomized, double-blind, single oral dose, two groups, placebo-controlled study with 2 dose sequences preset
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Being tested
- MY008211A tablets, Placebo
- 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
Subjects of Group A receive MY008211A tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.
PlaceboDrug
Subjects of Group A receive placebo tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.
| Study group | Role | What they receive |
|---|---|---|
| Group A, Sequence 1, Dose 1 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. Receives: Drug: MY008211A tablets |
| Group A, Sequence 2, Dose 2 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 7. Receives: Drug: MY008211A tablets |
| Group B, Sequence 1, Dose 1 | Placebo comparator | Participants randomized to receive MY008211A tablets or placebo on Day 1. Receives: Drug: Placebo |
| Group B, Sequence 2, Dose 2 | Placebo comparator | Participants randomized to receive MY008211A tablets or placebo on Day 7. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 2 weeks
Secondary outcomes (9)
Cmax (Maximum plasma concentration)
Cmax of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
Tmax (Time to maximum plasma concentration)
Tmax of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
t1/2 (Terminal elimination half-life time)
t1/2 of prodrug and active metabolite (if necessary)
Measured: 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)
AUC0-t of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
AUC0-∞ (Area under the plasma concentration-time curve extrapolated from time 0 to infinity)
AUC0-∞ of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
CL/F (Apparent clearance)
CL/F of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
Vz/F (Apparent volume of distribution)
Vz/F of prodrug and active metabolite (if necessary)
Measured: up to 2 weeks
The incidence and severity of adverse events to assess safety and tolerability
such as laboratory abnormalities
Measured: up to 3 weeks
Other Electrocardiogram (ECG) parameters
Such as T-wave morphology or absence, U-wave presence and absence, HR, RR interval, PR interval, QRS wave complex
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion27 Sep 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyan Li, PhD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543459
- Sponsor's protocol ID
- MY008211-1-07
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trade secrets
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Single Oral Dose, Placebo-controlled Study to Evaluate the Effect of MY008211A Tablets on QTc Interval in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT06543459
- Acronym / sponsor ID
- MY008211-1-07
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 27 Sep 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 9 Aug 2024 (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.
A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects
Detailed description
This is a single-center, randomized, double-blind, single oral dose, two groups, placebo-controlled study with 2 dose sequences preset
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A, Sequence 1, Dose 1 | Experimental | Drug: MY008211A tabletsParticipants randomized to receive MY008211A tablets or placebo on Day 1. |
| Group A, Sequence 2, Dose 2 | Experimental | Drug: MY008211A tabletsParticipants randomized to receive MY008211A tablets or placebo on Day 7. |
| Group B, Sequence 1, Dose 1 | Placebo comparator | Drug: PlaceboParticipants randomized to receive MY008211A tablets or placebo on Day 1. |
| Group B, Sequence 2, Dose 2 | Placebo comparator | Drug: PlaceboParticipants randomized to receive MY008211A tablets or placebo on Day 7. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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);
- 18≤ 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.
Key exclusion criteria (27 listed)
- 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 torsades de pointes (TDP) or other risk factors for malignant arrhythmias, or short QT syndrome, long QT syndrome, sudden unexplained death or drowning in youth (≤ 40 years old), or a family history of a first-degree relative (i.e., biological parent, sibling, or child) of sudden infant death syndrome, or other heart disease that the investigators determined was not suitable for inclusion;
- 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；
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 tabletsSubjects of Group A receive MY008211A tablets on Day 1 of both Sequence, wash-out period is 6 Days at least. | Drug | Group A, Sequence 1, Dose 1, Group A, Sequence 2, Dose 2 |
| PlaceboSubjects of Group A receive placebo tablets on Day 1 of both Sequence, wash-out period is 6 Days at least. | Drug | Group B, Sequence 1, Dose 1, Group B, Sequence 2, Dose 2 |
Primary outcome
ΔΔQTcF (Using Fridericia Formula as the Primary Method for QT Interval Correction)
Time frame: up to 2 weeks
Placebo-corrected, baseline-adjusted QTc interval of prodrug and active metabolite (if necessary)
9 secondary outcomes
Cmax (Maximum plasma concentration)
Time frame: up to 2 weeks
Tmax (Time to maximum plasma concentration)
Time frame: up to 2 weeks
t1/2 (Terminal elimination half-life time)
Time frame: 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)
Time frame: up to 2 weeks
AUC0-∞ (Area under the plasma concentration-time curve extrapolated from time 0 to infinity)
Time frame: up to 2 weeks
CL/F (Apparent clearance)
Time frame: up to 2 weeks
Vz/F (Apparent volume of distribution)
Time frame: up to 2 weeks
The incidence and severity of adverse events to assess safety and tolerability
Time frame: up to 3 weeks
Other Electrocardiogram (ECG) parameters
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. Trade secrets
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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.
Haiyan Li, PhD principal investigator
PI
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 27 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuhui Hu, master (021-51158605 ext. 86, huyuhui@createrna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔΔQTcF (Using Fridericia Formula as the Primary Method for QT Interval Correction) (time frame: up to 2 weeks). 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 9 Aug 2024.