NCT05828472

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation, and multiple-dose study to evaluate safety, tolerability, PK and PD of MY008211A Tablets in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

April 13, 2023

Last Update Submit

September 5, 2023

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of adverse events to assess safety and tolerability

    such as laboratory abnormalities

    up to 31 days

Secondary Outcomes (4)

  • Maximum Plasma Concentration (Cmax) Of MY008211A tablets

    up to 10 days

  • Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A

    up to 10 days

  • Area Under The Concentration Versus Time Curve (AUC) Of MY008211A

    up to 10 days

  • Half Life (t1/2) Of MY008211A

    up to 10 days

Other Outcomes (1)

  • Changes in serum LDH levels from baseline

    up to 10 days

Study Arms (4)

Group 1：Dose1

EXPERIMENTAL

8 subjects received Dose 1 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days

Drug: MY008211A tabletsDrug: MY008211A tablets matched placebo

Group 2：Dose2

EXPERIMENTAL

8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days

Drug: MY008211A tabletsDrug: MY008211A tablets matched placebo

Group 3：Dose3

EXPERIMENTAL

8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days

Drug: MY008211A tabletsDrug: MY008211A tablets matched placebo

Group 4: Dose4

EXPERIMENTAL

8 subjects received Dose 4 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days

Drug: MY008211A tabletsDrug: MY008211A tablets matched placebo

Interventions

MY008211A tabletsDRUG

MY008211A tablets, low/moderate/high dose orally, for 7 days

Also known as: no other name
Group 1：Dose1Group 2：Dose2Group 3：Dose3Group 4: Dose4
MY008211A tablets matched placeboDRUG

MY008211A tablets matched placebo, low/moderate/high dose orally, for 7 days

Also known as: placebo
Group 1：Dose1Group 2：Dose2Group 3：Dose3Group 4: Dose4

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ 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;
  • ACYW135 meningococcal vaccine, pneumococcal vaccine were voluntarily administered at least 2 weeks before MY008211A tablet administration
  • The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

You may not qualify if:

  • 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;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Study Officials

  • Wei feng, Ph.D

    Wuhan Createrna Science and Technology Co., Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 25, 2023

Study Start

January 10, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)