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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06213844




Registration number
NCT06213844
Ethics application status
Date submitted
10/01/2024
Date registered
19/01/2024
Date last updated
7/03/2024

Titles & IDs
Public title
A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics
Scientific title
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
Secondary ID [1] 0 0
CIBI3002A101AU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3002
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Single dose of Placebo administered subcutaneously on Day 1

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


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

Treatment: Drugs: Placebo
Single dose of Placebo, administered subcutaneously on Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with AEs/SAEs
Timepoint [1] 0 0
Baseline up to Day 36
Secondary outcome [1] 0 0
PK parameter: Cmax
Timepoint [1] 0 0
Baseline up to Day 36
Secondary outcome [2] 0 0
PK parameter: tmax
Timepoint [2] 0 0
Baseline up to Day 36
Secondary outcome [3] 0 0
PK parameter: AUC
Timepoint [3] 0 0
Baseline up to Day 36
Secondary outcome [4] 0 0
Immunogenicity profiles
Timepoint [4] 0 0
Baseline up to Day 36
Secondary outcome [5] 0 0
PD profile (only in asthmatics): TARC (CCL17)
Timepoint [5] 0 0
Baseline up to Day 36
Secondary outcome [6] 0 0
PD profile (only in asthmatics): IL-13
Timepoint [6] 0 0
Baseline up to Day 36
Secondary outcome [7] 0 0
PD profile (only in asthmatics): IgE
Timepoint [7] 0 0
Baseline up to Day 36
Secondary outcome [8] 0 0
PD profile (only in asthmatics): Eosinophil
Timepoint [8] 0 0
Baseline up to Day 36
Secondary outcome [9] 0 0
Clinical profile (only in asthmatics): FeNO
Timepoint [9] 0 0
Baseline up to Day 36
Secondary outcome [10] 0 0
Clinical profile (only in asthmatics): Spirometry
Timepoint [10] 0 0
Baseline up to Day 36

Eligibility
Key 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%.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06213844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sam Francis
Address 0 0
Country 0 0
Phone 0 0
0385939801
Fax 0 0
Email 0 0
s.francis@nucleusnetwork.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06213844