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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06012578




Registration number
NCT06012578
Ethics application status
Date submitted
17/08/2023
Date registered
25/08/2023

Titles & IDs
Public title
Study Evaluating ISM5411 Administered Orally to Healthy Volunteers
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of ISM5411 in Healthy Subjects
Secondary ID [1] 0 0
ISM5411-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ISM5411
Treatment: Drugs - Placebo

Experimental: ISM5411 -

Placebo comparator: Placebo -


Treatment: Drugs: ISM5411
Investigational Drug

Treatment: Drugs: Placebo
ISM5411 Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411.
Timepoint [1] 0 0
Up to 7 days after last dose.
Primary outcome [2] 0 0
Number of participants with clinically significant changes in vital signs
Timepoint [2] 0 0
Up to 7 days after last dose.
Primary outcome [3] 0 0
Number of participants with clinically significant changes in in chemistry laboratory values
Timepoint [3] 0 0
Up to 7 days after last dose
Primary outcome [4] 0 0
Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings
Timepoint [4] 0 0
Up to 7 days after last dose
Primary outcome [5] 0 0
Number of participants with clinically significant changes in physical examinations
Timepoint [5] 0 0
Up to 7 days after last dose
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax) of ISM5411
Timepoint [1] 0 0
Day 1 through Day 17
Secondary outcome [2] 0 0
Time at which the maximum plasma concentration occurred (tmax) of ISM5411
Timepoint [2] 0 0
Day 1 through Day 17
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ISM5411
Timepoint [3] 0 0
Day 1 through Day 17
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of ISM5411
Timepoint [4] 0 0
Day 1 through Day 17
Secondary outcome [5] 0 0
Elimination rate constant (?z) of ISM5411
Timepoint [5] 0 0
Day 1 through Day 17
Secondary outcome [6] 0 0
Elimination half-life (t1/2) of ISM5411
Timepoint [6] 0 0
Day 1 through Day 17
Secondary outcome [7] 0 0
Apparent volume of distribution (Vz/F) of ISM5411
Timepoint [7] 0 0
Day 1 through Day 17
Secondary outcome [8] 0 0
Apparent total plasma clearance (CL/F) of ISM5411
Timepoint [8] 0 0
Day 1 through Day 17
Secondary outcome [9] 0 0
Mean residence time (MRT) of ISM5411
Timepoint [9] 0 0
Day 1 through Day 17
Secondary outcome [10] 0 0
Renal clearance rate (CLR) of ISM5411
Timepoint [10] 0 0
Day 1 through Day 17
Secondary outcome [11] 0 0
Accumulative excretion (Ae) of ISM5411
Timepoint [11] 0 0
Day 1 through Day 17
Secondary outcome [12] 0 0
Fractional excretion (fe) of ISM5411
Timepoint [12] 0 0
Day 1 through Day 17
Secondary outcome [13] 0 0
Relative bioavailability (fed/fasted) of ISM5411
Timepoint [13] 0 0
Day 1 through Day 17

Eligibility
Key inclusion criteria
1. Subjects who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are able to complete the study in accordance with the protocol requirements.
2. Subjects (including their partners) who have no plan to become pregnant and voluntarily use effective contraception as described in section 8.1 from screening to 3 months after the last dose.
3. Male and female subjects aged 18-55 years (inclusive).
4. Body weight =50 kg for males and =45 kg for females, with a body mass index (BMI = weight (kg)/height2 (m2)) of 18 ~ 32 kg/m2 (inclusive).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Allergy to the IP or any of its ingredients, or allergic constitution (allergy to more than 1 drugs and food).
2. History of dysphagia or any gastrointestinal surgery (appendicectomy and cholecystectomy are excluded) or disease that affects drug absorption and/or elimination.
3. Presence of clinically relevant diseases evidenced by clinical findings, which are making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric or cardiovascular and cerebrovascular diseases).
4. Presence of abnormal and clinically significant medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests, abdominal color Doppler ultrasound, or other investigations at screening (Repeat testing will be allowed by the investigator discretion).
5. Positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV-Ab) in the viral serology testing at screening.
6. Smoking > 5 cigarettes or an equivalent amount of tobacco per day, or consuming = 14 units of alcohol per week (1 unit of alcohol ˜ 25 mL of spirits/100 mL of wine/285 mL of beer) within 1 months prior to screening or unwilling to abstain from smoking or drinking during the study.
7. Subjects who are positive for urine drug testing at screening or Day-1, or have a history of drug abuse or narcotic use in the past five years (Repeat testing will be allowed by the investigator discretion).
8. Subjects who have donated blood or lost a significant amount of blood (>400 mL) within 1 months prior to screening, or who plan to donate blood during the study or within 1 month after the end of the study.
9. Subjects who have undergone major surgical procedures (major visceral, organ, or bone surgeries) that may affect the study in the judgment of the investigator within 3 months prior to screening, or who intend to have such procedures during the study.
10. Intolerance to vein puncture, or presence of a history of blood phobia or trypanophobia.
11. Use of any prescription drugs within 14 days prior to the admission. Use of counter medication / vitamins / supplements within 7 days prior to admission (with the exception of contraception, occasional paracetamol, and standard dose of multivitamins).
12. Subjects who have receipt of any study drug or participated in any medical device clinical studies within 1 month (or 5 half-lives, whichever is longer) prior to screening.
13. Vaccination with any live or attenuated vaccine within 1 month prior to screening.
14. Any acute disease or acute attack of any chronic disease within 28 days prior to screening.
15. Consumption of any caffeinated food or beverages (such as coffee, strong tea, cola, chocolate, etc.), xanthine-rich food (such as anchovies, sardines, bovine liver, bovine kidney, etc.), food that induces or inhibits liver metabolizing enzymes (such as dragon fruits, mango, grapefruit, pomegranate, etc.) and beverages made thereof, or food or beverages containing alcohol, or presence of other factors that may affect the absorption, distribution, metabolism or excretion of the drug (such as strenuous exercise) within 48 hours prior to IP.
16. Female subjects who are in lactation or positive for serum pregnancy test during the screening period or study course.
17. Subjects who, in the judgment of the investigator, are not suitable for participation in the study.

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 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
8/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/09/2024
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
InSilico Medicine Hong Kong Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Yichen Liu
Address 0 0
Country 0 0
Phone 0 0
+86 18817554306
Fax 0 0
Email 0 0
Insilico-Clinicaltrial@insilico.ai
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06012578