None listed
Conditions
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.
Interventions
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
Pa
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.
Sponsors
Insilico Medicine Hong Kong Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed