Pharmacokinetics and Tolerability of Trinbelimab in healthy volunteers
Phase 1
- Registration Number
- CTRI/2023/10/058310
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Post-menopausal female subjects.
BMI between 18.5 and 29.9 kg/m2
Able to give voluntary written consent
Exclusion Criteria
Rh-D positive post menopausal female and who are positive for anti-D IgG antibodies
Positive test for pregnancy
History or presence of clinically significant disease
Known hypersensitivity to antiD immunoglobulin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the PK parameters of single dose (300 mcg) of TrinbelimabTimepoint: Predose <br/ ><br>Post dose - 8 hours and 24 hours, then every day till day 10, every 2 weeks till day 113
- Secondary Outcome Measures
Name Time Method To assess the tolerability of TrinbelimabTimepoint: Throughout the study till the end of study AEs will be captured