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A Study of Single-dose MY008211A in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05642585
Recruitment Status : Completed
First Posted : December 8, 2022
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
Wuhan Createrna Science and Technology Co., Ltd

Brief Summary:
The trial is the first human trial. The safety, tolerability, PK and PD of MY008211A Tablets will be evaluated in healthy subjects.

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria Drug: MY008211A tablets Drug: Placebo Phase 1

Detailed Description:
This is a single ascending dose, randomized, double-blind study,with 5 dose groups preset.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Doses Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic/Pharmacodynamics Characteristics of MY008211A Tablets in Healthy Adult Volunteers
Actual Study Start Date : May 27, 2022
Actual Primary Completion Date : June 4, 2023
Actual Study Completion Date : June 4, 2023


Arm Intervention/treatment
Experimental: Group 1: Dose1
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 2: Dose2
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 3: Dose3
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 4: Dose4
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 5: Dose5
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 6: Dose6
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name

Experimental: Group 7: Dose7
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Drug: MY008211A tablets
Single oral
Other Name: no name

Drug: Placebo
Single oral
Other Name: no name




Primary Outcome Measures :
  1. The incidence and severity of adverse events to assess safety and tolerability [ Time Frame: up to 21days ]
    such as laboratory abnormalities


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) Of MY008211A tablets [ Time Frame: up to 72 hours postdose ]
    Maximum Plasma Concentration (Cmax)

  2. Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A [ Time Frame: up to 72 hours postdose ]
    The Maximum Plasma Concentration (Tmax)

  3. Area Under The Concentration Versus Time Curve (AUC) Of MY008211A [ Time Frame: up to 72 hours postdose ]
    Area Under The Concentration Versus Time Curve (AUC)

  4. Half Life (t1/2) Of MY008211A [ Time Frame: up to 72 hours postdose ]
    Half Life (t1/2)

  5. Changes in serum C3 levels from baseline [ Time Frame: up to 72 hours postdose ]
    serum C3 levels

  6. Changes in serum LDH levels from baseline [ Time Frame: up to 72 hours postdose ]
    serum LDH levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05642585


Locations
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China, Hunan
The Third Hospital of Changsha
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Wuhan Createrna Science and Technology Co., Ltd
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Responsible Party: Wuhan Createrna Science and Technology Co., Ltd
ClinicalTrials.gov Identifier: NCT05642585    
Other Study ID Numbers: MY008211-1-01
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Trade secrets

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases