A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers

NCT06560593 | Not Yet Recruiting Phase 1

• 1 other identifier: NTQ5082-24101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK/PD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.

Conditions

Complement-mediated Hemolytic Diseases

Outcome Measures

Primary Outcomes (1)

• the safety and tolerability

  Safety and tolerability as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG

  up to 21 days

Secondary Outcomes (21)

• AUC0-last in plasma of part 1

  up to 11 days

• AUC0-∞ in plasma of part 1

  up to 11 days

• Cmax in plasma of part 1

  up to 11 days

• Tmax in plasma of part 1

  up to 11 days

• t1/2 in plasma of part 1

  up to 11 days

Study Arms (2)

single ascending dose

EXPERIMENTAL

single ascending dose, randomized, double-blind study

Drug: NTQ5082; Drug: Placebo

multiple ascending dose

EXPERIMENTAL

multiple ascending dose, randomized, double-blind study

Drug: NTQ5082; Drug: Placebo

Interventions

NTQ5082 DRUG

single ascending dose, randomized, double-blind study，with 8 dose groups preset. The first cohort will be the sentinel group, consisted of 2 subjects receiving NTQ5082 capsules. The remaining cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.

multiple ascending dose; single ascending dose

Placebo DRUG

multiple ascending dose, randomized, double-blind study，with 3 dose groups preset. All cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.

multiple ascending dose; single ascending dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, ≥18 years and ≤45 years in age.
• kg/m2≤BMI≤26.0 kg/m2, and male weight must be ≥50 kg, female weight must be ≥45 kg;
• Those who sign an informed consent form before the experiment and fully understand the content, process, and possible adverse reactions of the experiment;
• The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
• \. (Part 2 only) The Subjects voluntarily receive ACYW135 group meningococcal vaccine and pneumococcal vaccine at least 14 days before NTQ5082 capsule administration. If the subjects has received pneumococcal vaccine within 5 years, or ACYW135 group meningococcal vaccine within 3 years, repeated vaccination is not required.

You may not qualify if:

• Participants who have participated in any other drug clinical trials and used the investigational drug within 3 months prior to the trial;
• Individuals who have chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years, and who are still clinically significant according to researchers;
• Individuals with clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);
• Known or suspected history of immunodeficiency (such as frequent recurrent infections), genetic or acquired complement deficiency;
• There is a clear history of capsule microbial infection within the first 6 months of screening; Including but not limited to: history of infection with Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila;
• Individuals with a history of tuberculosis infection or currently suffering from tuberculosis infection;
• Active systemic bacterial, viral, or fungal infection within 14 days prior to administration;
• Fever (≥ 38 ℃) occurred within 7 days before administration;
• Individuals with a history of allergies to experimental preparations, any of their components or related preparations, or to drugs, food or other substances;
• Those who cannot tolerate venous puncture or have a history of dizziness or needle fainting;
• Patients who have undergone surgery within 6 months prior to the use of the investigational drug, as determined by the researcher, that may affect drug absorption, distribution, metabolism, and excretion; Or have undergone surgical procedures within 4 weeks prior to using the investigational drug; Or those who plan to undergo surgical procedures during the trial period;
• Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 2 weeks before using the study drug; Or screen for drugs with a duration of less than 5 half lives (whichever is longer);
• Individuals who have received the vaccine or live attenuated vaccine within 14 days prior to using the investigational drug, or who plan to receive the vaccine during the trial period;
• Individuals with QTc\>450 milliseconds (male) or QTc\>470 milliseconds (female) during screening;
• Individuals who have donated blood or experienced significant blood loss (\>400mL) within 3 months prior to the use of the investigational drug, those who have received blood transfusions or used blood products, or those who intend to donate blood or blood components during or within 3 months after the end of the trial;

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

Study Sites (1)

The Third hospital of Changsha

Changsha, Hunan, 410035, China

Location

Central Study Contacts

Yumeng Zhou

CONTACT

86-025-85109999; yumeng_zhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)