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

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI3002 in Healthy Participants and Participants With Mild to Moderate Asthma

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: IBI3002

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sam Francis; Phone Number: 0385939801; Email: s.francis@nucleusnetwork.com.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Nucleus Network Pty Ltd
      • Contact: Sam Francis; Phone Number: 0385939801; Email: s.francis@nucleusnetwork.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved informed consent form 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 effective methods 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 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%.

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 the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial.
5. 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.
6. History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
7. 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.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Single dose of Placebo administered subcutaneously on Day 1	Drug: Placebo; Single dose of Placebo, administered subcutaneously on Day 1; Other Names: ICS, alone or in combination with LABA
Experimental: IBI3002; Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6) administered subcutaneously on Day 1	Drug: IBI3002; Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1; Other Names: ICS, alone or in combination with LABA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with AEs/SAEs	Incidence of adverse events and severe adverse events	Baseline up to Day 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter: Cmax	Observed maximum plasma concentration	Baseline up to Day 36
PK parameter: tmax	Time to achieve Cmax	Baseline up to Day 36
PK parameter: AUC	Area under the plasma concentration-time curve	Baseline up to Day 36
Immunogenicity profiles	Frequency and titers of anti-drug antibody (ADA)	Baseline up to Day 36
PD profile (only in asthmatics): TARC (CCL17)	Change from baseline in peripheral blood TARC (CCL17) level	Baseline up to Day 36
PD profile (only in asthmatics): IL-13	Change from baseline in peripheral blood IL-13 level	Baseline up to Day 36
PD profile (only in asthmatics): IgE	Change from baseline in peripheral blood Immunoglobulin	Baseline up to Day 36
PD profile (only in asthmatics): Eosinophil	Change from baseline in peripheral blood eosinophil level	Baseline up to Day 36
Clinical profile (only in asthmatics): FeNO	Change from baseline in Fractional exhaled Nitric Oxide	Baseline up to Day 36
Clinical profile (only in asthmatics): Spirometry	Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1)	Baseline up to Day 36

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 26, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CIBI3002A101AU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No