ClinicalTrials.gg
Not yet recruitingNCT06543459Updated Aug 9, 2024

To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects

A Phase 1 interventional study of MY008211A tablets and Placebo in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Wuhan Createrna Science and Technology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

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

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 51 studies in Hemoglobinuria, Paroxysmal with a site in China — 21 open to participants now, 29 under way, 11 of them phase 3. Hemoglobinuria, Paroxysmal · China.

Planned enrollment
43rd of 47
16 · median 40
Started
2024
with 11 others
Phase 1
13 of 51
5 open now
Primary completion
2024-09
later than 2 of 28 live
Registered
22nd of 51
by date
Lead sponsor
8 of 51
Wuhan Createrna Science and Technology Co., Ltd

Among the 51 studies in Hemoglobinuria, Paroxysmal with a site in China, this one is the 43rd largest by planned enrollment of the 47 interventional ones, is one of 12 that started in 2024, is one of 13 in phase 1, reaches primary completion later than 2 of the 28 other live ones, and was the 22nd registered.

By phase

51 studies; the count open now beside each. This study's row is marked.

Phase 317 · 7 open
Phase 1this study13 · 5 open
Phase 213 · 4 open
Observational4 · 2 open
No phase1 · 1 open
Phase 1/21 · 1 open
Phase 2/31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2012; this study’s year is marked. 12 started in 2024.

Size and results

Median enrollment 40 across the 47 interventional studies, 402 across the 4 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 51 studies in Hemoglobinuria, Paroxysmal with a site in China, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
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. 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 Form (ICF);
  2. 18≤ age ≤ 45 years old, male or female Chinese adult volunteers;
  3. Body weight: ≥50 kg for male, ≥45 kg for female; (BMI): 19.0-26.0 kg/m2 (inclusive) at screening;
  4. Volunteers should be able to communicate well with the investigator, understand and comply with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. 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;
  3. Volunteers with torsades de pointes (TDP) or other risk factors for malignant arrhythmias, or short 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;
  4. Volunteers with hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia or hypocalcemia and judged by the investigator to have clinical significance;
  5. History of known or suspected immunodeficiency (e.g., history of frequent recurrent infections), inherited or acquired complement deficiency;
  6. 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;
  7. 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;
  8. Volunteers with previous or current history of TB infection or with positive lymphobacteria culture + interferon test;
  9. Active systemic bacterial, viral, or fungal infection within 14 days pre-dose;
  10. Fever (≥ 38 ℃) within 7 days pre-dose;
  11. Volunteers with a history of 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 thereof as judged by the investigator;
  12. 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;
  13. Volunteers with 12- 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;
  14. Volunteers who administrated any other clinical study drug or enrolled in any Interventional clinical trial within 3 months before screening;
  15. 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;
  16. 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;
  17. Volunteers who received a vaccine or within 14 days pre-dose, or who plan to receive a vaccine during the study;
  18. Volunteers with difficulty in blood collection or cannot tolerate intravenous puncture;
  19. Volunteers with a history of drug use or substance abuse or with positive urine drug abuse screening test;
  20. Volunteers with any positive result of virological test;
  21. 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;
  22. 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;
  23. 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;
  24. Volunteers who have special requirements for diet and cannot abide by the uniform diet;
  25. 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 measures (such as complete abstinence, condoms, contraceptive rings, surgical sterilization, etc.);
  26. 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;
  27. Volunteers have other reasons for not fit for participating in the study as judged by the investigator.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Group A, Sequence 1, Dose 1

    Participants randomized to receive MY008211A tablets or placebo on Day 1.

    Drug: MY008211A tablets

  • Experimental
    Group A, Sequence 2, Dose 2

    Participants randomized to receive MY008211A tablets or placebo on Day 7.

    Drug: MY008211A tablets

  • Placebo comparator
    Group B, Sequence 1, Dose 1

    Participants randomized to receive MY008211A tablets or placebo on Day 1.

    Drug: Placebo

  • Placebo comparator
    Group B, Sequence 2, Dose 2

    Participants randomized to receive MY008211A tablets or placebo on Day 7.

    Drug: Placebo

Interventions

  • Subjects of Group A receive MY008211A tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.

  • DrugPlacebo

    Subjects of Group A receive placebo tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: up to 2 weeks

Secondary outcomes

  1. Cmax (Maximum plasma concentration)

    Cmax of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

  2. Tmax (Time to maximum plasma concentration)

    Tmax of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

  3. t1/2 (Terminal elimination half-life time)

    t1/2 of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

  4. 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)

    Time frame: up to 2 weeks

  5. AUC0-∞ (Area under the plasma concentration-time curve extrapolated from time 0 to infinity)

    AUC0-∞ of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

  6. CL/F (Apparent clearance)

    CL/F of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

  7. Vz/F (Apparent volume of distribution)

    Vz/F of prodrug and active metabolite (if necessary)

    Time frame: up to 2 weeks

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

    such as laboratory abnormalities

    Time frame: up to 3 weeks

  9. Other Electrocardiogram (ECG) parameters

    Such as T-wave morphology or absence, U-wave presence and absence, HR, RR interval, PR interval, QRS wave complex

    Time frame: up to 2 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Trade secrets

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

Start is estimated for Aug 2024; primary completion for Sep 2024, 1 month later.

Of 19 phase 1 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 1 month is below that.

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

Registered
Aug 2, 2024
First posted
Aug 9, 2024
StartEst.
Aug 10, 2024
Primary completionEst.
Sep 27, 2024
CompletionEst.
Dec 13, 2024
Last update
Aug 9, 2024
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 Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06543459
Lead sponsor
Wuhan Createrna Science and Technology Co., Ltd
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Aug 10, 2024 (estimated)
Primary completion
Sep 27, 2024 (estimated)
Completion
Dec 13, 2024 (estimated)
Last update
Aug 9, 2024

Study contacts

Yuhui Hu, master
Contact
huyuhui@createrna.com
021-51158605 ext. 86
Haiyan Li, PhD
principal investigator · PI

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lanoracopan

Start the discussion