A Single Microdose Study to Evaluate the Pharmacokinetics of INS018_055 in Healthy Participants

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001541897
• Lead Sponsor: Insilico Medicine Hong Kong Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-11
• Study Completion: 2021-11-23
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified