Pharmacokinetics and Tolerability of Trinbelimab in healthy volunteers

A Prospective, Single-Dose, Single-Period Study to Evaluate the Pharmacokinetics and Tolerability of Trinbelimab (Recombinant Anti Rho-D Immunoglobulin) of Bharat Serums and Vaccines Ltd., India in Healthy, Adult, Rhesus-D Negative Non Sensitized Postmenopausal Female Subjects - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058310

Enrollment

Registered

2023-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Trinbelimab Injection (Recombinant Anti Rho-D Immunoglobulin), manufactured by Bharat Serums and Vaccines Limited, India.: Dose single dose of 300 mcg Route - IM Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: Post-menopausal female subjects. BMI between 18.5 and 29.9 kg/m2 Able to give voluntary written consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate the PK parameters of single dose (300 mcg) of TrinbelimabTimepoint: Predose Post dose - 8 hours and 24 hours, then every day till day 10, every 2 weeks till day 113	—

Secondary

Measure	Time frame
To assess the tolerability of TrinbelimabTimepoint: Throughout the study till the end of study AEs will be captured	—

Countries

India

Contacts

Public ContactDr Ramesh Jagannathan

Bharat Serums and Vaccines Ltd.

Ramesh.Jagannathan@bsvgroup.com02245043456

Outcome results