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

NCT06213844 | Completed Phase 1

• 1 other identifier: CIBI3002A101AU
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants; Asthma

Outcome Measures

Primary Outcomes (1)

• Number of participants with AEs/SAEs

  Incidence of adverse events and severe adverse events

  Baseline up to Day 36

Secondary Outcomes (10)

• PK parameter: Cmax

  Baseline up to Day 36

• PK parameter: tmax

  Baseline up to Day 36

• PK parameter: AUC

  Baseline up to Day 36

• Immunogenicity profiles

  Baseline up to Day 36

• PD profile (only in asthmatics): TARC (CCL17)

  Baseline up to Day 36

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single dose of Placebo administered subcutaneously on Day 1

Drug: Placebo

IBI3002

EXPERIMENTAL

Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6) administered subcutaneously on Day 1

Drug: IBI3002

Interventions

IBI3002 DRUG

Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1

Also known as: ICS, alone or in combination with LABA

IBI3002

Placebo DRUG

Single dose of Placebo, administered subcutaneously on Day 1

Also known as: ICS, alone or in combination with LABA

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
• Participants must be between 18 and 55 years old, inclusive.
• Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
• Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study.
• Participants with asthma must have:
• Documented physician diagnosis of asthma for at least 12 months prior to screening 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 equivalent total daily dose of ICS, alone or in combination with LABA) for the last 3 months prior to screening;
• Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) \> 70%.

You may not qualify if:

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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Asthma

Interventions

Single Person

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: February 26, 2024
• Primary Completion: July 22, 2025
• Study Completion: September 11, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)