Complement-mediated Hemolytic DiseasesPhase 1NCT06560593
A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers
A Phase 1 study testing NTQ5082 in people with Complement-mediated Hemolytic Diseases, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Complement-mediated Hemolytic Diseases
- What is being tested?
- NTQ5082
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 3. (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.
Who cannot join
- 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;
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- 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;
- Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within the past year before using research drugs; Or those who test positive for urinary toxicity screening;
- Smokers or those who have smoked more than 5 cigarettes per day in the 3 months prior to using the study drug, or those who cannot stop using any tobacco products during the trial period;
- Alcoholics or frequent drinkers within the 6 months prior to the experiment, who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Those who are unwilling to stop drinking alcohol or any alcoholic products during the trial period; Or those who test positive for alcohol breath test;
- Individuals who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) daily, or who do not agree to stop drinking tea, coffee, and/or caffeinated beverages during the trial period;
- Individuals who consume a diet (including grapefruit or grapefruit products, etc.) that may affect the metabolism of the investigational drug within 7 days prior to use, or who are deemed by the researcher to have other diets that may affect the absorption, distribution, metabolism, or excretion of the drug, or who do not agree to stop consuming the aforementioned foods during the trial period;
- Those who have special dietary requirements and cannot follow a uniform diet;
- Female subjects are pregnant or breastfeeding women; Or engaging in unprotected sexual activity within 2 weeks prior to the use of the investigational drug; Those who have used oral contraceptives within 30 days prior to the use of the study drug, or those who have used long-acting estrogen or progesterone injections or implants within 6 months prior to the use of the study drug;
- If the subject (or their partner) has a pregnancy plan, sperm and egg donation plan, or is unwilling to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive rings, partner ligation, etc.) within 3 months after the last dose of medication from the time of signing the informed consent form;
- Physical examination, electrocardiogram, abdominal ultrasound, chest radiograph, laboratory tests (blood routine, reticulocyte count, procalcitonin, high-sensitivity C-reactive protein, urine routine, blood biochemistry, thyroid function, coagulation function, D-dimer, blood transfusion, blood pregnancy), vital signs, and clinically significant abnormalities in various examinations (subject to the judgment of the research doctor);
- Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses
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
- Being tested
- NTQ5082, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTQ5082Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| single ascending dose | Experimental | single ascending dose, randomized, double-blind study Receives: Drug: NTQ5082; Drug: Placebo |
| multiple ascending dose | Experimental | multiple ascending dose, randomized, double-blind study Receives: Drug: NTQ5082; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 21 days
Secondary outcomes (21)
AUC0-last in plasma of part 1
Measured: up to 11 days
AUC0-∞ in plasma of part 1
Measured: up to 11 days
Cmax in plasma of part 1
Measured: up to 11 days
Tmax in plasma of part 1
Measured: up to 11 days
t1/2 in plasma of part 1
Measured: up to 11 days
Aet1-t2 in urine of part 1
Measured: up to 11 days
Ae0-t in urine of part 1
Measured: up to 11 days
Fe0-t in urine of part 1
Measured: up to 11 days
CLr in urine of part 1
Measured: up to 11 days
AUC0-τ in plasma after the first dosing of part 2
Measured: up to 21 days
AUC0-∞ in plasma after the first dosing of part 2
Measured: up to 21 days
Tmax in plasma after the first dosing of part 2
Measured: up to 21 days
Cmax in plasma after the first dosing of part 2
Measured: up to 21 days
AUC0-τ,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
AUC0-t,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
AUC0-∞,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
Tmax,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
Cmax,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
Ctrough,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
Cavg,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
t1/2,ss in plasma under steady-state conditions (ss) of part 2
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement-mediated Hemolytic DiseasesStudies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560593
- Sponsor's protocol ID
- NTQ5082-24101
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT06560593
- Acronym / sponsor ID
- NTQ5082-24101
- Conditions
- Complement-mediated Hemolytic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single ascending dose | Experimental | Drug: NTQ5082, Drug: Placebosingle ascending dose, randomized, double-blind study |
| multiple ascending dose | Experimental | Drug: NTQ5082, Drug: Placebomultiple ascending dose, randomized, double-blind study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- 3. (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.
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTQ5082single 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. | Drug | multiple ascending dose, single ascending dose |
| Placebomultiple 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. | Drug | multiple ascending dose, single ascending dose |
Primary outcome
the safety and tolerability
Time frame: up to 21 days
Safety and tolerability as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG
21 secondary outcomes
AUC0-last in plasma of part 1
Time frame: up to 11 days
AUC0-∞ in plasma of part 1
Time frame: up to 11 days
Cmax in plasma of part 1
Time frame: up to 11 days
Tmax in plasma of part 1
Time frame: up to 11 days
t1/2 in plasma of part 1
Time frame: up to 11 days
Aet1-t2 in urine of part 1
Time frame: up to 11 days
Ae0-t in urine of part 1
Time frame: up to 11 days
Fe0-t in urine of part 1
Time frame: up to 11 days
CLr in urine of part 1
Time frame: up to 11 days
AUC0-τ in plasma after the first dosing of part 2
Time frame: up to 21 days
AUC0-∞ in plasma after the first dosing of part 2
Time frame: up to 21 days
Tmax in plasma after the first dosing of part 2
Time frame: up to 21 days
Cmax in plasma after the first dosing of part 2
Time frame: up to 21 days
AUC0-τ,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
AUC0-t,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
AUC0-∞,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
Tmax,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
Cmax,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
Ctrough,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
Cavg,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
t1/2,ss in plasma under steady-state conditions (ss) of part 2
Time frame: up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTQ5082 in people with Complement-mediated Hemolytic Diseases, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumeng Zhou (86-025-85109999, yumeng_zhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safety and tolerability (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.