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A Study of Single-dose MY008211A in Healthy Adults

Primary Purpose

Paroxysmal Nocturnal Hemoglobinuria

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MY008211A tablets
Placebo
Sponsored by
Wuhan Createrna Science and Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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: 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; 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.

Sites / Locations

  • The Third Hospital of Changsha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: Dose1

Group 2: Dose2

Group 3: Dose3

Group 4: Dose4

Group 5: Dose5

Group 6: Dose6

Group 7: Dose7

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

The incidence and severity of adverse events to assess safety and tolerability
such as laboratory abnormalities

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) Of MY008211A tablets
Maximum Plasma Concentration (Cmax)
Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A
The Maximum Plasma Concentration (Tmax)
Area Under The Concentration Versus Time Curve (AUC) Of MY008211A
Area Under The Concentration Versus Time Curve (AUC)
Half Life (t1/2) Of MY008211A
Half Life (t1/2)
Changes in serum C3 levels from baseline
serum C3 levels
Changes in serum LDH levels from baseline
serum LDH levels

Full Information

First Posted
November 30, 2022
Last Updated
September 5, 2023
Sponsor
Wuhan Createrna Science and Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05642585
Brief Title
A Study of Single-dose MY008211A in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
June 4, 2023 (Actual)
Study Completion Date
June 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Createrna Science and Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial is the first human trial. The safety, tolerability, PK and PD of MY008211A Tablets will be evaluated in healthy subjects.
Detailed Description
This is a single ascending dose, randomized, double-blind study,with 5 dose groups preset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Nocturnal Hemoglobinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Dose1
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 2: Dose2
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 3: Dose3
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 4: Dose4
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 5: Dose5
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 6: Dose6
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Arm Title
Group 7: Dose7
Arm Type
Experimental
Arm Description
Participants randomized to receive MY008211A tablets or placebo on Day 1.
Intervention Type
Drug
Intervention Name(s)
MY008211A tablets
Other Intervention Name(s)
no name
Intervention Description
Single oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
no name
Intervention Description
Single oral
Primary Outcome Measure Information:
Title
The incidence and severity of adverse events to assess safety and tolerability
Description
such as laboratory abnormalities
Time Frame
up to 21days
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) Of MY008211A tablets
Description
Maximum Plasma Concentration (Cmax)
Time Frame
up to 72 hours postdose
Title
Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A
Description
The Maximum Plasma Concentration (Tmax)
Time Frame
up to 72 hours postdose
Title
Area Under The Concentration Versus Time Curve (AUC) Of MY008211A
Description
Area Under The Concentration Versus Time Curve (AUC)
Time Frame
up to 72 hours postdose
Title
Half Life (t1/2) Of MY008211A
Description
Half Life (t1/2)
Time Frame
up to 72 hours postdose
Title
Changes in serum C3 levels from baseline
Description
serum C3 levels
Time Frame
up to 72 hours postdose
Title
Changes in serum LDH levels from baseline
Description
serum LDH levels
Time Frame
up to 72 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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; 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.
Facility Information:
Facility Name
The Third Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Trade secrets

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A Study of Single-dose MY008211A in Healthy Adults

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