Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001541897
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
11/11/2021
Date last updated
30/03/2022
Date data sharing statement initially provided
11/11/2021
Date results information initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single Microdose Study to Evaluate the Pharmacokinetics of INS018_055 in Healthy Participants
Scientific title
A Phase 0 Single Microdose Study to evaluate the Pharmacokinetics of INS018_055 in Healthy Participants
Secondary ID [1] 305325 0
INS018_055
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF) 323644 0
Condition category
Condition code
Respiratory 321183 321183 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open label Phase 0 exploratory first in human study to determine the PK of a single dose of INS018_055 administered IV to healthy adult volunteers.
The study will enroll 8 eligible adults. Safety oversight for this study will be provided by the Investigator, Sponsor's Medical monitor (MM) and/or delegate, and an independent Medical Monitor (MM).
Investigational Product (IP): INS018_055
Presentation: Liquid in a glass vial: 2 ml at 50 microgram/ml
Mode of Administration: Intravenous
Participants will be admitted to the CRU on Day 1 where they will be domiciled until Day 2 (i.e. 24 hours after administration of INS018_055). On Day1, participants will be administered a single dose of INS018_055 via IV injection and will be monitored for safety. Blood for PK analysis will be collected before and after (i.e. 5, 15, and 30 minutes, and 1, 2, 4, and 8 hours) the administration of INS018_055.
On Day 2 (i.e. after 24 hours after INS018_055 administration), a final blood sample for PK analysis will be collected and participants will undergo safety assessments before being discharged from CRU.
Intervention code [1] 321735 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328973 0
To determine the PK of plasma INS018_055 after a single IV microdose administered to healthy participants.
Parameters: volume of distribution, elimination half-life, and clearance of INS018_055.
Timepoint [1] 328973 0
Blood for PK analysis will be collected at pre dose (within 30 minutes prior to dosing) and 0, 5, 15, and 30 minutes and 1, 2, 4, 8, and 24 hours after the administration of INS018_055.
Primary outcome [2] 328974 0
Safety of the single dose of INS018_055, based on incidence and severity of Adverse events (AEs), use of concomitant medications, abnormal clinically significant vital signs, ECG, telemetry and laboratory tests.
Timepoint [2] 328974 0
Day 1 and Day 2.
Additional safety tests (hematology, chemistry, urinalysis, 12-lead ECG) may be performed whenever clinically indicated, at the investigator's discretion.
All AEs will be documented once daily from the time of consent to Day 8.
Secondary outcome [1] 401010 0
Nil
Timepoint [1] 401010 0
Nil

Eligibility
Key inclusion criteria
1. Healthy female or male aged 18 to 55 years (both inclusive) at screening.
2. BMI of 17.50 to 30.50 kg/m2; and a total body weight more than 50 kg at screening and Day 1.
3. Sufficient venous access for the purposes of the study.
Participants must be a non-smoker and must not have used any tobacco products within two months prior to screening.
4. Females must be non-pregnant and non-lactating.
5. Willing and able to attend the trial visits and complete study assessments.
6. Signed HREC approved Informed Consent Form.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Positive toxicology screening panel
2. Major surgery or significant trauma within 28 days (4 weeks) prior to screening
3. BP more than 150 mm of Hg (systolic) or more than 95 mm of Hg (diastolic)
4. Abnormalities in the clinical laboratory tests at screening
5. A white Blood Cell count less than 4.5 x 109/L, including history of benign ethnic neutropenia
6. Absolute neutrophil count of less than 2 X 109/L
7. hematocrit below 0.4 for males and 0.35 for females.
8. Use of any IP or investigational medical device within 30 days prior to Screening
9.Use of prescription or non-prescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer)
10. significant blood loss within 56 days prior to dosing.
11. History of sensitivity to heparin or heparin-induced thrombocytopenia
12. Have a history of any lymphoproliferative disorder
13. Have a clinically significant infection currently or within 6 months of first dose of study
drug
14. Test positive at Screening for HIV, hepatitis B or C viruses
15. History of malignancy or severe allergic reactions
16. Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2021
Actual
22/11/2021
Date of last participant enrolment
Anticipated
22/11/2021
Actual
22/11/2021
Date of last data collection
Anticipated
Actual
23/11/2021
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20529 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 35311 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 309691 0
Commercial sector/Industry
Name [1] 309691 0
Insilico Medicine Hong Kong Limited
Country [1] 309691 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Insilico Medicine Hong Kong Limited
Address
307 A, Core Building 1, No.1 Science Park, East Avenue, Pak Shek Kok, New Territories, Hong Kong.
Country
Hong Kong
Secondary sponsor category [1] 310714 0
None
Name [1] 310714 0
Address [1] 310714 0
Country [1] 310714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309460 0
Bellberry HREC Limited
Ethics committee address [1] 309460 0
Bellberry HREC Limited,
123 Glen Osmond Road, Eastwood,
SA 5063.
Ethics committee country [1] 309460 0
Australia
Date submitted for ethics approval [1] 309460 0
24/08/2021
Approval date [1] 309460 0
01/10/2021
Ethics approval number [1] 309460 0

Summary
Brief summary
This is First in human, open label, single centre, exploratory study to determine safety and PK characteristics of INS018_055 after a single IV microdose administration in healthy participants. This study will enrol 8 eligible adults. The study will consist of 3 periods:
Screening-(Day -28 to Day-1)- After completion of ICF and eligibility check participants will be enrolled in the study.
Treatment period (Day-1 to Day -2)- On Day 1, baseline and safety assessments will be performed and participants will be administered a single dose of IP via IV injection and monitored for safety. Blood for PK analysis will be collected pre and post dosing.
Follow up (Day 8[± 1day]- Participants will return to CRU on Day 8 to undergo safety assessments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114230 0
Dr Angela Rowland
Address 114230 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace, Adelaide, South Australia, 5000
Country 114230 0
Australia
Phone 114230 0
+61 439 682 089
Fax 114230 0
Email 114230 0
[email protected]
Contact person for public queries
Name 114231 0
Dr Andrey Kukharenko
Address 114231 0
Insilico Medicine Hong Kong Limited
Unit 307 A, Core Building 1, No. 1 Science Park East Avenue, Pak Shek Kok, New Territories, Hong Kong.
Country 114231 0
Hong Kong
Phone 114231 0
+852 8192 5741
Fax 114231 0
Email 114231 0
[email protected]
Contact person for scientific queries
Name 114232 0
Dr Andrey Kukharenko
Address 114232 0
Insilico Medicine Hong Kong Limited
Unit 307 A, Core Building 1, No. 1 Science Park East Avenue, Pak Shek Kok, New Territories, Hong Kong.
Country 114232 0
Hong Kong
Phone 114232 0
+852 8192 5741
Fax 114232 0
Email 114232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.