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

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 - Comparative PK study of DRL_AB, US*licensed and EU-approved Orencia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51534

Enrollment

Registered

2022-04-12

Start date

2022-06-14

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

rheumatoid arthritis autoimmune disease rheumatoid arthritis

Interventions

Not applicable.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To demonstrate pharmacokinetic similarity of DRL_AB versus RP and RMP and between the RP and the RMP after administration of a 750 mg single IV dose.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of DRL_AB, RP and RMP. To assess the immunogenicity of DRL_AB, RP and RMP.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)