adalimumab biobetter (ZB002) / Zenas BioPharma, Xencor - LARVOL DELTA

A Phase 1 Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of ZB002, an Anti-TNFα mAb Designed for Extended Half-life, in Healthy Volunteers (ACR Convergence 2024) - "Background/Purpose: ZB002 is a recombinant human monoclonal antibody (mAb) that targets human TNFα with an Fv domain identical in amino acid sequence to adalimumab and was designed to have an extended half-life. This study demonstrated that ZB002 was well tolerated, and the safety profile was consistent with anti-TNF treatment of a HV population at the doses studied. Observed ZB002 half-life and confirmation of target engagement warrants continued clinical development."

Clinical • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants with Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Zenas BioPharma (USA), LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A PHASE 1 SINGLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF ZB002, AN ANTI-TNFΑ MAB DESIGNED FOR EXTENDED HALF-LIFE, IN HEALTHY VOLUNTEERS (EULAR 2024) - "Background: ZB002 is a recombinant human monoclonal antibody (mAb) that targets human TNFα with an Fv domain identical in amino acid sequence to adalimumab and was designed to have an extended half-life. This study demonstrated that ZB002 was safe and well tolerated at the doses studied. Observed ZB002 half-life and confirmation of target engagement warrants continued clinical development."

Clinical • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TNFA

A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Zenas BioPharma (USA), LLC | N=48 ➔ 72 | Trial completion date: Mar 2024 ➔ Jul 2025 | Trial primary completion date: Mar 2024 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Zenas BioPharma (USA), LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Zenas BioPharma (USA), LLC | Active, not recruiting ➔ Recruiting

Enrollment open

A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Zenas BioPharma (USA), LLC | Trial completion date: Sep 2023 ➔ Apr 2024 | Trial primary completion date: Sep 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date

A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Zenas BioPharma (USA), LLC | Recruiting ➔ Active, not recruiting

Enrollment closed