ClinicalTrials.gg
RecruitingNCT07909837Updated Nov 3, 2026

A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers

A Phase 1 interventional study of NTQ6179 and NTQ6179 placebo in Acromegaly, sponsored by Nanjing Chia-tai Tianqing Pharmaceutical. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Nanjing Chia-tai Tianqing Pharmaceutical (part of Sino Biopharmaceutical Limited) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 3, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of single oral doses of NTQ6179 tablets in healthy participants. A total of 56 healthy participants will be enrolled in 7 sequential dose cohorts, with an allocation ratio of NTQ6179 to placebo of 6:2 in each cohort.

02

Conditions studied

  • Acromegaly

Browse trials for

03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's planned enrollment of 56 is above the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Nanjing Chia-tai Tianqing Pharmaceutical is the lead sponsor of 19 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy males or females aged ≥ 18 and ≤ 55 years (both inclusive).
  2. Women must be non-pregnant and non-lactating; status according to medical history confirmed by follicle-stimulating hormone (FSH) > 40 U/L at screening, or surgical sterilization.
  3. (BMI) between 19.0 and 26.0 kg/m2 (both inclusive) at screening, with a body weight ≥ 50 kg for males and ≥ 45 kg for females.
  4. Full understanding of the study and voluntary signing of the form (ICF) before undergoing any study-specific procedures.
  5. Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. Participation in any other drug clinical trial and use of the product within 3 months prior to admission.
  2. Chronic or active gastrointestinal diseases (e.g., esophageal diseases, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, or active gastrointestinal bleeding) or gastrointestinal surgery within 3 years prior to admission, with conditions at present as judged by the investigator.
  3. Definite diseases of the nervous, cardiovascular (e.g., heart disease, arrhythmia, etc.), digestive, respiratory, endocrine, urinary, hematological, immune, or reproductive systems, or metabolic disorders, or other diseases requiring medical intervention or unsuitable for the clinical trial (e.g., history of psychiatric disorders).
  4. Any neuroendocrine tumors and related diseases (including but not limited to acromegaly, growth hormone deficiency, carcinoid syndrome, and Cushing's syndrome).
  5. Past or current thyroid dysfunction, cholelithiasis or complications of cholelithiasis, pancreatic exocrine insufficiency (e.g., steatorrhea, impaired absorption of dietary fat, pancreatic injury, pancreatitis, etc.) and related diseases.
  6. Past or current glucose metabolism disorders (e.g., hypoglycemia, hyperglycemia, diabetes mellitus, impaired glucose tolerance, etc.).
  7. Diarrhea, abdominal pain, nausea, headache, dizziness, or arthralgia within 7 days prior to admission.
  8. Allergy to the investigational formulation and any of its components or related formulations, or a history of allergy to drugs, foods, or other substances.
  9. Inability to tolerate venipuncture, or a history of hemophobia or needle phobia.
  10. Surgery judged by the investigator to affect drug absorption, distribution, metabolism, or excretion within 6 months prior to admission; or surgery within 4 weeks prior to admission; or planned surgery during the study period.
  11. Use of any medications (including prescription drugs, over-the-counter drugs, herbal medicines, Chinese patent medicines, and dietary supplements, etc.) within 14 days prior to admission; or within 5 half-lives of the medication at screening (whichever is longer).
  12. Vaccination or administration within 14 days prior to admission, or planned vaccination during the study period.
  13. > 450 msec for males or QTcF > 470 msec for females at screening.
  14. Blood donation or massive blood loss (> 400 mL) within 3 months prior to admission, or receipt of blood transfusion or blood products; or intention to donate blood or blood components during the study period or within 3 months after the end of the study.
  15. Drug abuse, or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to admission; or a positive urine drug screening test.
  16. Smoking habit, or smoking within 3 months prior to admission, or inability to abstain from any tobacco products during the study period; or a positive urine cotinine test.
  17. Alcohol abuse, or regular alcohol consumption within 6 months prior to admission (i.e., > 14 units of alcohol per week; 1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine); or unwillingness to abstain from alcohol or any alcohol-containing products during the study period; or a positive breath alcohol test.
  18. Inability to comply with the prohibition of tea, coffee, and other caffeinated or alcoholic beverages, smoking, and strenuous exercise throughout the study period.
  19. Consumption of a diet that may affect drug metabolism in vivo (including grapefruit or grapefruit products, etc.) within 7 days prior to admission; or other diets that, in the opinion of the investigator, may affect drug absorption, distribution, metabolism, or excretion; or unwillingness to abstain from such diets during the study period.
  20. Special dietary requirements or inability to comply with the standardized diet.
  21. The participant (or their partner) with plans for pregnancy, sperm or oocyte donation, or sperm or oocyte cryopreservation from the signing of the ICF until 3 months after the last dose; or unwillingness to adopt one or more non-pharmacological measures (e.g., complete abstinence, intrauterine device, or partner sterilization, etc.).
  22. Clinically significant abnormalities in vital signs, physical examination, laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function panel (5 items), insulin, glucagon, serum adrenocorticotropic hormone [ACTH], prolactin, pancreatic enzymes [pancreatic amylase and pancreatic lipase]), the four tests for transfusion safety, 12-lead , chest posteroanterior radiograph, abdominal ultrasound, echocardiography, or pregnancy test (females only) at screening or admission, as judged by the investigator.
  23. \< 80 mL/min.
  24. Any other circumstances that may prevent the participant from completing the study, or unsuitability for the trial as judged by the investigator.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    NTQ6179 (Single Ascending Dose)

    Participants received a single oral dose of NTQ6179 tablets under fasting conditions in 1 of 7 sequential dose cohorts; each cohort comprised 8 participants randomized in a ratio of 6:2 (NTQ6179 : placebo).

    Drug: NTQ6179

  • Placebo comparator
    NTQ6179 placebo

    Participants received a single oral dose of NTQ6179 placebo tablets under fasting conditions in 1 of 7 sequential dose cohorts; each cohort comprised 8 participants randomized in a ratio of 6:2 (NTQ6179 : placebo).

    Drug: NTQ6179 placebo

Interventions

  • DrugNTQ6179

    NTQ6179 tablets, an oral non-peptide small-molecule somatostatin receptor subtype 2 (SSTR2) agonist, administered orally as a single dose with approximately 240 milliliters (mL) of water under fasting conditions (at least 10 hours of overnight fasting prior to dosing).

  • DrugNTQ6179 placebo

    NTQ6179 placebo tablets administered orally as a single dose with approximately 240 milliliters (mL) of water under fasting conditions (at least 10 hours of overnight fasting prior to dosing).

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)

    Safety and tolerability, including the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)

    Time frame: Up to the end of follow-up (Day 13 ± 1)

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: Up to 120 hours post-dose

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 120 hours post-dose

  3. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: Up to 120 hours post-dose

  4. Elimination Half-Life (t1/2)

    Time frame: Up to 120 hours post-dose

  5. Apparent Oral Clearance (CL/F)

    Time frame: Up to 120 hours post-dose

  6. Apparent Volume of Distribution (Vd/F)

    Time frame: Up to 120 hours post-dose

07

Study locations

1 of 1 sites recruiting
08

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore the safety and tolerabilityNow Incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)Time frame: Up to the end of follow-up (Day 13 ± 1)
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore the safety and tolerabilityNow Incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)Time frame: Up to the end of follow-up (Day 13 ± 1)
    + 1 other change: verification date
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07909837
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Apr 23, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Yu meng Zhou
Contact
zhouyumeng@njzdqt.com
86-025-85109999

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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