Health TrialsbyHealthPanel

A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers

ConditionComplement-mediated Hemolytic Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female, ≥18 years and ≤45 years in age.

19.0 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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: single ascending doseExperimental treatment 2 interventions
Group B: multiple ascending doseExperimental treatment 2 interventions

Trial outcomes

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

Time frame
up to 21 days

Secondary outcomes

1

AUC0-last in plasma of part 1

Time frame
up to 11 days
2

AUC0-∞ in plasma of part 1

Time frame
up to 11 days
3

Cmax in plasma of part 1

Time frame
up to 11 days
4

Tmax in plasma of part 1

Time frame
up to 11 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Chia-tai Tianqing Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: