Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06304740




Registration number
NCT06304740
Ethics application status
Date submitted
3/03/2024
Date registered
12/03/2024
Date last updated
27/09/2024

Titles & IDs
Public title
Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants
Scientific title
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants
Secondary ID [1] 0 0
IMG-007-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMG-007
Treatment: Drugs - Placebo

Experimental: IMG-007 Cohort 1 (Healthy Participant) - Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo.

Experimental: IMG-007 Cohort 2 (Healthy Participant) - Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo.

Experimental: IMG-007 Cohort 3 (Healthy Participant) - Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo.


Treatment: Drugs: IMG-007
Subcutaneous injection of IMG-007

Treatment: Drugs: Placebo
Subcutaneous Injection of Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Event Evaluation
Timepoint [1] 0 0
Up to 18 weeks
Secondary outcome [1] 0 0
Pharmacokinetic Parameters, Cmax
Timepoint [1] 0 0
Up to 18 weeks
Secondary outcome [2] 0 0
Pharmacokinetic Parameters, Tmax
Timepoint [2] 0 0
Up to 18 weeks
Secondary outcome [3] 0 0
Pharmacokinetic Parameters, AUC0-t
Timepoint [3] 0 0
Up to 18 weeks

Eligibility
Key inclusion criteria
Key

* Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females
* Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
* Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.
* Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
* Major surgery = 4 weeks before the Baseline Visit or planned major surgical procedure during the study.
* Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose.
* Drug or alcohol abuse.
* Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose.
* Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
* Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection.
* Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit.
* Hypersensitivity to study treatment or other biologics
* Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit.

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2024
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inmagene LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.
Trial website
https://clinicaltrials.gov/study/NCT06304740
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06304740