A Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study of DRL_AB, US licensed Reference Abatacept (Orencia®) and EU approved Reference (Orencia®), Administered by the Intravenous Route to Male Normal Healthy Volunteers

Completed

• Conditions: rheumatoid arthritis; autoimmune disease

• Registration Number: NL-OMON51534
• Lead Sponsor: Dr. Reddys Laboratories Ltd., Biologics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Healthy Male volunteers, 18 to 50 years of age (both age inclusive) at the
time of signing informed consent.
2. In general, good health as determined by a qualified physician based on a
comprehensive medical history, physical examination including vital signs,
laboratory haematology, clinical chemistry, urinalysis and 12-lead
electrocardiogram (ECG) before randomization.
3. Body mass index between 18.5-30.0 kg/m2 (both inclusive) and body weight of
60.0 - 100.0 kg (both inclusive).
4. Screening parameters (vital signs, physical examination, clinical laboratory
tests, 12-lead ECG, thyroid function) within the normal range or outside the
normal range then assessed as clinically non-significant by the Investigator
(unless the value constitutes an explicit exclusion criterion).

Exclusion Criteria

1. Positive test result for Quantiferon- TB Gold test, syphilis, hepatitis B,
hepatitis C, or HIV-1 or 2.
2. Vaccination with live vaccines within 3 months prior to Screening or
intention to receive live vaccines during the trial or up to 3 months after the
administration of the study drug. Non-live vaccines should be administered at
least a week before the study drug administration to
avoid interference with immunization.
3. Any prior exposure to abatacept or to any other agent directly acting on
CTLA4 or the CD28-CD80 co-stimulation pathway (eg. pembrolizumab (Keytruda),
ipilimumab (Yervoy), nivolumab (Opdivo) and atezolizumab (Tecentriq)) including
investigational products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate pharmacokinetic similarity of DRL_AB versus RP and RMP and<br /><br>between the RP and the RMP after administration of a 750 mg<br /><br>single IV dose.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of DRL_AB, RP and RMP.<br /><br>To assess the immunogenicity of DRL_AB, RP and RMP.</p><br>