AcromegalyPhase 1NCT07909837
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
A Phase 1 study testing NTQ6179 in people with Acromegaly, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- NTQ6179
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females aged ≥ 18 and ≤ 55 years (both inclusive).
- Women must be non-pregnant and non-lactating; postmenopausal status according to medical history confirmed by follicle-stimulating hormone (FSH) > 40 U/L at screening, or surgical sterilization.
- Body mass index (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.
- Full understanding of the study and voluntary signing of the informed consent form (ICF) before undergoing any study-specific procedures.
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
Who cannot join
- Participation in any other drug clinical trial and use of the investigational product within 3 months prior to admission.
- 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 clinically significant conditions at present as judged by the investigator.
- 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).
- Any neuroendocrine tumors and related diseases (including but not limited to acromegaly, growth hormone deficiency, carcinoid syndrome, and Cushing's syndrome).
- 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.
- Past or current glucose metabolism disorders (e.g., hypoglycemia, hyperglycemia, diabetes mellitus, impaired glucose tolerance, etc.).
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- Diarrhea, abdominal pain, nausea, headache, dizziness, or arthralgia within 7 days prior to admission.
- Allergy to the investigational formulation and any of its components or related formulations, or a history of allergy to drugs, foods, or other substances.
- Inability to tolerate venipuncture, or a history of hemophobia or needle phobia.
- 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.
- 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).
- Vaccination or live attenuated vaccine administration within 14 days prior to admission, or planned vaccination during the study period.
- QTcF > 450 msec for males or QTcF > 470 msec for females at screening.
- 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.
- 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.
- 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.
- 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.
- Inability to comply with the prohibition of tea, coffee, and other caffeinated or alcoholic beverages, smoking, and strenuous exercise throughout the study period.
- 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.
- Special dietary requirements or inability to comply with the standardized diet.
- 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 contraceptive measures (e.g., complete abstinence, intrauterine device, or partner sterilization, etc.).
- 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 electrocardiogram, chest posteroanterior radiograph, abdominal ultrasound, echocardiography, or pregnancy test (females only) at screening or admission, as judged by the investigator.
- Creatinine clearance < 80 mL/min.
- Any other circumstances that may prevent the participant from completing the study, or unsuitability for the trial as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
Hong yun Wang, +86-18611513192, wanghy@pumch.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of Single Oral Doses of NTQ6179 Tablets in Healthy Participants
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.
- Conditions
- Acromegaly
- Being tested
- NTQ6179, NTQ6179 placebo
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTQ6179Drug
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).
NTQ6179 placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| NTQ6179 (Single Ascending Dose) | Experimental | 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). Receives: Drug: NTQ6179 |
| NTQ6179 placebo | Placebo comparator | 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). Receives: Drug: NTQ6179 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to the end of follow-up (Day 13 ± 1)
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
Measured: Up to 120 hours post-dose
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 120 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: Up to 120 hours post-dose
Elimination Half-Life (t1/2)
Measured: Up to 120 hours post-dose
Apparent Oral Clearance (CL/F)
Measured: Up to 120 hours post-dose
Apparent Volume of Distribution (Vd/F)
Measured: Up to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start23 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- 56 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
- NCT07909837
- Sponsor's protocol ID
- NTQ6179-101
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of Single Oral Doses of NTQ6179 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07909837
- Acronym / sponsor ID
- NTQ6179-101
- Conditions
- Acromegaly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTQ6179 (Single Ascending Dose) | Experimental | Drug: NTQ6179Participants 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). |
| NTQ6179 placebo | Placebo comparator | Drug: NTQ6179 placeboParticipants 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males or females aged ≥ 18 and ≤ 55 years (both inclusive).
- Women must be non-pregnant and non-lactating; postmenopausal status according to medical history confirmed by follicle-stimulating hormone (FSH) > 40 U/L at screening, or surgical sterilization.
- Body mass index (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.
- Full understanding of the study and voluntary signing of the informed consent form (ICF) before undergoing any study-specific procedures.
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
Key exclusion criteria (24 listed)
- Participation in any other drug clinical trial and use of the investigational product within 3 months prior to admission.
- 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 clinically significant conditions at present as judged by the investigator.
- 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).
- Any neuroendocrine tumors and related diseases (including but not limited to acromegaly, growth hormone deficiency, carcinoid syndrome, and Cushing's syndrome).
- 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.
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 |
|---|---|---|
| NTQ6179NTQ6179 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). | Drug | NTQ6179 (Single Ascending Dose) |
| NTQ6179 placeboNTQ6179 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). | Drug | NTQ6179 placebo |
Primary outcome
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)
Safety and tolerability, including the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Up to 120 hours post-dose
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 120 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Up to 120 hours post-dose
Elimination Half-Life (t1/2)
Time frame: Up to 120 hours post-dose
Apparent Oral Clearance (CL/F)
Time frame: Up to 120 hours post-dose
Apparent Volume of Distribution (Vd/F)
Time frame: Up to 120 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
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 NTQ6179 in people with Acromegaly, 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 24 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu meng Zhou (86-025-85109999, zhouyumeng@njzdqt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 3 Nov 2026.