Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05353972




Registration number
NCT05353972
Ethics application status
Date submitted
18/04/2022
Date registered
29/04/2022
Date last updated
28/06/2023

Titles & IDs
Public title
Evaluate IMG-007 in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants
Secondary ID [1] 0 0
IMG-007-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Cohort 1 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 2 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 3 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 4 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 5 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 6 - Single dose of IMG or placebo solution, intravenously administered

Experimental: Cohort 7 - Single dose of IMG or placebo solution, intravenously administered


Treatment: Drugs: IMG-007 or placebo
intravenously administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax) after infusion
Timepoint [1] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [2] 0 0
Time at which Cmax is observed after infusion (tmax)
Timepoint [2] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [3] 0 0
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Timepoint [3] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [4] 0 0
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Timepoint [4] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [5] 0 0
Half-life t½
Timepoint [5] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcome [6] 0 0
Incidence of anti-drug antibody (ADA) after infusion
Timepoint [6] 0 0
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;

Eligibility
Key inclusion criteria
1. Participants aged between 18 to 50 years (inclusive)
2. Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than 32 kg/m2 and a minimum body weight of 50 kg for males and 45 kg for females at both the Screening and Baseline visits.
3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
2. History of immunological abnormality
3. History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
4. History of anaphylaxis or significant reactions to foods, medications, or other allergens
5. Major surgery =4 weeks before Baseline visit.
6. History of malignancy or known current malignancy,
7. Participant has an active infection or history of infections
8. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibody to Hepatitis B core antigen (HBcAb) with positive test for HBV DNA (>500 IU/ml) or hepatitis C antibodies (HCV) at Screening visit.
9. History of asthma
10. Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
11. Participants with positive testing for COVID-19 at the Baseline visit.
12. Participants with clinically significantly abnormal laboratory values, as determined by the Investigator or medically qualified designee, i
13. Clinically significant abnormal findings at Screening or Baseline visits
14. Systolic blood pressure below 100 mmHg, at any time points prior to IMP administration
15. Use of any prescription medication
16. Use of over-the-counter medication
17. History of, or current substance abuse considered significant
18. Use of more than 5 tobacco/nicotine-containing products
19. Average alcohol consumption of more than 14 units/week for females and 21 units/week for males
20. Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
21. Live (attenuated) vaccination within 8 weeks before Screening or plan to be vaccinated by live (attenuated) vaccine during the trial
22. COVID-19 vaccination, or influenza vaccination(inactivated), within 14 days prior or planning to receive COVID-19 vaccination or influenza vaccination(inactivated) within 14 days post IMP administration.
23. Donated or lost more than 500 mL of blood or plasma within 3 months of Screening or received blood products within 8 weeks of Screening.
24. Pregnant or lactating women.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Schrader
Address 0 0
Linear
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05353972