TEDPhase 1NCT07182552
Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics of NTB003 in Healthy Participants
A Phase 1 study testing NTB003 in people with TED, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial summary
This study is a randomized, double-blind, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of NTB003 injection in healthy volunteers. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- TED
- What is being tested?
- NTB003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Mar 2026
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Ensure good communication with the Investigator, understand and comply with all requirements of the study, voluntarily participate in the trial, and sign the informed consent form.
- 2. participants aged between 25 and 45 inclusive at the time of signing the informed consent form.
- 3. Body mass index (BMI) is 19.0 kg/m2≤BMI≤26.0 kg/m2, and men must weigh ≥50 kg and women must weigh≥45 kg.
- 4. Physical health and do not have any clinical diseases (including respiratory system, circulatory system, digestive system, nervous system, blood system, genitourinary system, endocrine system diseases) or mental illness (including depression, schizophrenia, etc.) during the screening interview.
- 5. Physical examination, electrocardiogram, vital signs, laboratory and other related examinations are normal or abnormalities are of no clinical significance at screening.
- 6. Agree to use reliable contraceptive methods with their partners during the trial; female volunteers of childbearing age must have a negative pregnancy test before the first use of the study drug.
Who cannot join
- Known or suspected allergy to the investigational drug or any of its components, or predisposition to allergy.
- Previous treatment with any anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
- Presence of scars, tattoos, moles, tenderness, bruising, erythema, induration, or damage at the intended injection site.
- Difficulty with blood collection, inability to tolerate venous indwelling catheterization, or a history of syncope due to venipuncture.
- Abnormal or did not have results for hepatitis B surface antigen, hepatitis C virus antibody, combined human immunodeficiency virus (HIV) antigen/antibody test, or Treponema pallidum antibody (TP-Ab).
- History or suspected history of diabetes mellitus, or fasting blood glucose or glycated hemoglobin (HbA1c) above the upper limit of normal during screening.
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- History of ear diseases, ear surgery, hearing impairment, or a family history of hearing disorders.
- History of thymic diseases such as thymoma or myasthenia gravis, or autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, or inflammatory bowel disease.
- Use of any medications within 2 weeks prior to screening, including prescription drugs, over-the-counter drugs, herbal medicines, traditional Chinese medicines, and dietary supplements.
- Any active or suspected bacterial, viral, or fungal infection within 4 weeks prior to screening, such as common cold, viral syndrome, influenza-like symptoms.
- Receipt of live attenuated or inactivated vaccines within 4 weeks prior to screening, or planned vaccination with such vaccines during the study period.
- Underwent surgical procedures within 3 months prior to screening, or plans to undergo surgery during the study period.
- Participation in any other clinical trial and receipt of an investigational drug within 3 months prior to screening.
- Blood donation or significant blood loss (>400 mL), receipt of blood transfusion or blood products within 3 months prior to screening, or plans to donate blood or blood components during the study or within 3 months after completion.
- Current smoker or history of smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from tobacco products during the study.
- History of alcohol abuse or regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); unwillingness to abstain from alcohol or alcohol-containing products during the study; or abnormal/unperformed breath alcohol test results.
- History of drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to screening; or positive/unperformed urine drug screening results.
- Special dietary requirements incompatible with a standardized diet.
- Occurrence of acute illness during the screening phase or prior to study drug administration.
- Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is a randomized, double-blind, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of NTB003 injection in healthy volunteers.
Read the detailed description
This study is a randomized, double-blind, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of NTB003 injection in healthy volunteers.
- Conditions
- TED
- Being tested
- NTB003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTB003Drug
NTB003 dose 1, dose 2, dose 3, dose 4
PlaceboDrug
Placebo dose 1, dose 2, dose 3, dose 4
| Study group | Role | What they receive |
|---|---|---|
| NTB003 dose 1, dose 2, dose 3, dose 4 | Experimental | Not described Receives: Drug: NTB003 |
| Placebo dose 1, dose 2, dose 3, dose 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability, including the 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: Day 0 up to 154 days for healthy participants
Secondary outcomes (6)
Pharmacokinetic parameter Cmax
Measured: Day 0 up to 154 days
Pharmacokinetic parameter Tmax
Measured: Day 0 up to 154 days
Pharmacokinetic parameter AUC
Measured: Day 0 up to 154 days
Pharmacokinetic parameter T1/2
Measured: Day 0 up to 154 days
Incidence of anti-drug antibody (ADA) development in NTB003 treated participants over time
Measured: Day 0 up to 154 days
PD indicator IGF-1 concentration and changes relative to baseline
Measured: Day 0 up to 154 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Jun 2025
- Primary completion23 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TEDStudies 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
- 40 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
- NCT07182552
- Sponsor's protocol ID
- NTB003-101
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 19 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics of NTB003 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07182552
- Acronym / sponsor ID
- NTB003-101
- Conditions
- TED
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 19 Sep 2025 (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 study is a randomized, double-blind, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of NTB003 injection in healthy volunteers.
Detailed description
This study is a randomized, double-blind, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of NTB003 injection in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTB003 dose 1, dose 2, dose 3, dose 4 | Experimental | Drug: NTB003 |
| Placebo dose 1, dose 2, dose 3, dose 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Ensure good communication with the Investigator, understand and comply with all requirements of the study, voluntarily participate in the trial, and sign the informed consent form.
- 2. participants aged between 25 and 45 inclusive at the time of signing the informed consent form.
- 3. Body mass index (BMI) is 19.0 kg/m2≤BMI≤26.0 kg/m2, and men must weigh ≥50 kg and women must weigh≥45 kg.
- 4. Physical health and do not have any clinical diseases (including respiratory system, circulatory system, digestive system, nervous system, blood system, genitourinary system, endocrine system diseases) or mental illness (including depression, schizophrenia, etc.) during the screening interview.
- 5. Physical examination, electrocardiogram, vital signs, laboratory and other related examinations are normal or abnormalities are of no clinical significance at screening.
Key exclusion criteria (20 listed)
- Known or suspected allergy to the investigational drug or any of its components, or predisposition to allergy.
- Previous treatment with any anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
- Presence of scars, tattoos, moles, tenderness, bruising, erythema, induration, or damage at the intended injection site.
- Difficulty with blood collection, inability to tolerate venous indwelling catheterization, or a history of syncope due to venipuncture.
- Abnormal or did not have results for hepatitis B surface antigen, hepatitis C virus antibody, combined human immunodeficiency virus (HIV) antigen/antibody test, or Treponema pallidum antibody (TP-Ab).
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 |
|---|---|---|
| NTB003NTB003 dose 1, dose 2, dose 3, dose 4 | Drug | NTB003 dose 1, dose 2, dose 3, dose 4 |
| PlaceboPlacebo dose 1, dose 2, dose 3, dose 4 | Drug | Placebo dose 1, dose 2, dose 3, dose 4 |
Primary outcome
Safety and tolerability, including the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)
Time frame: Day 0 up to 154 days for healthy participants
Safety and tolerability, including the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs)
6 secondary outcomes
Pharmacokinetic parameter Cmax
Time frame: Day 0 up to 154 days
Pharmacokinetic parameter Tmax
Time frame: Day 0 up to 154 days
Pharmacokinetic parameter AUC
Time frame: Day 0 up to 154 days
Pharmacokinetic parameter T1/2
Time frame: Day 0 up to 154 days
Incidence of anti-drug antibody (ADA) development in NTB003 treated participants over time
Time frame: Day 0 up to 154 days
PD indicator IGF-1 concentration and changes relative to baseline
Time frame: Day 0 up to 154 days
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 19 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NTB003 in people with TED, 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 6 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability, including the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs (TRAEs), and serious adverse events (SAEs) (time frame: Day 0 up to 154 days for healthy participants). 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 Sep 2025.