A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics

Last updated: March 5, 2024
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Asthma

Treatment

Placebo

IBI3002

Clinical Study ID

NCT06213844
CIBI3002A101AU
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must sign an Institutional Review Board (IRB) approved informed consentform before any study specific procedures.
  2. Participants must be between 18 and 55 years old, inclusive.
  3. Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
  4. Participants of childbearing potential and their partners should use highly effectivemethods of birth control during the study and until 6 months after the study.
  5. Participants with asthma must have:
  • Documented physician diagnosis of asthma for at least 12 months prior toscreening and confirmed by the investigator;
  • Elevated FeNO defined as ≥ 25ppb;
  • Documented and stable GINA 2023 recommended Step 1~3 controller treatment (defined as ≤ 250μg fluticasone propionate dry powder formulation equivalenttotal daily dose of ICS, alone or in combination with LABA) for the last 3 monthsprior to screening;
  • Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) > 70%.

Exclusion

Exclusion Criteria:

  1. History of allergies to any components of IBI3002 or placebo.
  2. History of blood or needle sickness, or those who cannot tolerate venipuncture.
  3. Female participants who are pregnant or breastfeeding at screening or randomization.
  4. History of participating in a clinical trial within 1 month or 5 half-lives of thetest drug (whichever is longer) prior to randomization, or those who are currentlyparticipating in a clinical trial.
  5. History of severe infection or significant injury within 6 months, or surgery within 3months, or any infection requiring systemic medication within 1 month prior toscreening or randomization.
  6. History of live or attenuated vaccination within 1 month prior to randomization, orthose who plan to be vaccinated during the study.
  7. For asthmatics only: history of a life-threatening asthma attack that requiredmechanical ventilation and/or was associated with hypercapnia, respiratory arrest orhypoxic seizures within the last 5 years prior to randomization.
  8. For asthmatics only: history of asthma worsen or exacerbation resulting in emergencyroom (ER) visits or overnight hospitalizations, or an increase in asthma maintenancetherapy, or use of systemic glucocorticoids within the last 3 months prior torandomization.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
February 26, 2024
Estimated Completion Date:
February 15, 2025

Connect with a study center

  • Nucleus Network Pty Ltd

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

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