Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics of NTB003 in Healthy Participants

NCT07182552 | Enrolling By Invitation Phase 1

• 1 other identifier: NTB003-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TED

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 0 up to 154 days for healthy participants

Secondary Outcomes (6)

• Pharmacokinetic parameter Cmax

  Day 0 up to 154 days

• Pharmacokinetic parameter Tmax

  Day 0 up to 154 days

• Pharmacokinetic parameter AUC

  Day 0 up to 154 days

• Pharmacokinetic parameter T1/2

  Day 0 up to 154 days

• Incidence of anti-drug antibody (ADA) development in NTB003 treated participants over time

  Day 0 up to 154 days

Study Arms (2)

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

Interventions

NTB003 DRUG

NTB003 dose 1, dose 2, dose 3, dose 4

NTB003 dose 1, dose 2, dose 3, dose 4

Placebo DRUG

Placebo dose 1, dose 2, dose 3, dose 4

Placebo dose 1, dose 2, dose 3, dose 4

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. participants aged between 25 and 45 inclusive at the time of signing the informed consent form.
• \. 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.
• \. 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.
• \. Physical examination, electrocardiogram, vital signs, laboratory and other related examinations are normal or abnormalities are of no clinical significance at screening.
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

Study Sites (1)

Aerospace Center Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 19, 2025
• Study Start: June 30, 2025
• Primary Completion: February 23, 2026
• Study Completion: March 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-08

Locations

CN (1)