A Study of Single-dose MY008211A in Healthy Adults

NCT05642585 | Completed Phase 1

• 1 other identifier: MY008211-1-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

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 21days

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) Of MY008211A tablets

  up to 72 hours postdose

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

  up to 72 hours postdose

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

  up to 72 hours postdose

• Half Life (t1/2) Of MY008211A

  up to 72 hours postdose

• Changes in serum C3 levels from baseline

  up to 72 hours postdose

Study Arms (7)

Group 1: Dose1

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 2: Dose2

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 3: Dose3

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 4: Dose4

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 5: Dose5

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 6: Dose6

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Group 7: Dose7

EXPERIMENTAL

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

Drug: MY008211A tablets; Drug: Placebo

Interventions

MY008211A tablets DRUG

Single oral

Also known as: no name

Group 1: Dose1; Group 2: Dose2; Group 3: Dose3; Group 4: Dose4; Group 5: Dose5; Group 6: Dose6; Group 7: Dose7

Placebo DRUG

Single oral

Also known as: no name

Group 1: Dose1; Group 2: Dose2; Group 3: Dose3; Group 4: Dose4; Group 5: Dose5; Group 6: Dose6; Group 7: Dose7

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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;
• 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;

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

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: November 30, 2022
• First Posted: December 8, 2022
• Study Start: May 27, 2022
• Primary Completion: June 4, 2023
• Study Completion: June 4, 2023
• Last Updated: September 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)