A study to compare how the body processes first and second generation RO7490677 (recombinant human pentraxin-2; rhPTX-2) drug products in healthy participants

Phase 1

Completed

• Conditions: Healthy participants; Not Applicable

• Registration Number: ISRCTN59409907
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38651245/ (added 24/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-22
• Study Completion: 2023-04-11
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Age between 18 and 70 years, both inclusive
2. Within body mass index (BMI) range 18.0 to 36.0 kilogram per square metre (kg/m²), both inclusive
3. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody total, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) p24 antigen/antibody screens
4. Negative screening test for active or latent Mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold Plus
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease, as determined by the investigator
2. History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
3. History or presence of any malignancy, except for completely excised basal cell or squamous cell carcinoma of the skin
4. History or presence of a clinically significant ECG abnormality, as determined by the investigator, or known history of family history of a prolonged QT interval syndrome
5. History or presence of atrial fibrillation
6. History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes, as determined by the investigator
7. History of active or latent TB, regardless of treatment history
8. Use of oral antibiotics within 4 weeks or IV antibiotics within 8 weeks prior to Screening
9. Administration of a vaccine (including seasonal flu, H1N1, and Coronavirus Disease 2019 [COVID-19] vaccine) in the past 30 days prior to dosing
10. Evidence of current/positive test result for severe acute respiratory syndrome coronavirus 2 (i.e., the virus that causes COVID-19) infection at Screening or Check-in
11. Donation of blood within 30 days prior to Screening through study completion, inclusive, or of plasma within 2 weeks prior to Screening through study completion, both inclusive
12. Receipt of blood products within 2 months prior to Check-in
13. Female participants who are pregnant, lactating, or breastfeeding.
Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified