CLINICAL TRIALS PROFILE FOR ABX464

Clinical Trials for ABX464

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02452242 ↗	Safety, PK and PD Study of ABX464 in Untreated HIV Patients	Completed	Abivax S.A.	Phase 2	ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.
NCT02731885 ↗	Food Effect on Pharmacokinetic Parameters of ABX464	Completed	Abivax S.A.	Phase 1	The goal of this study is to determine the impact of the food on the absorption of the ABX464.
NCT02735863 ↗	ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment	Completed	Abivax S.A.	Phase 2	This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).
NCT02792686 ↗	ABX464 First in Man Study	Completed	Abivax S.A.	Phase 1	This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).
NCT02990325 ↗	A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults	Completed	FLS-RS	Phase 1/Phase 2	The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.
NCT02990325 ↗	A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults	Completed	Abivax S.A.	Phase 1/Phase 2	The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.

Clinical Trial Conditions for ABX464

Condition Name

Condition Name for
Intervention	Trials
Ulcerative Colitis	8
Healthy Volunteers	3
Rheumatoid Arthritis	2
Crohn Disease	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Colitis, Ulcerative	8
Colitis	8
Ulcer	8
HIV Infections	3

Clinical Trial Locations for ABX464

Trials by Country

Trials by Country for
Location	Trials
Belgium	10
France	7
Spain	6
Hungary	5
Germany	5

Trials by US State

Trials by US State for
Location	Trials
Texas	1
Georgia	1
California	1

Clinical Trial Progress for ABX464

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	1
Phase 2	10

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for ABX464

Sponsor Name

Sponsor Name for
Sponsor	Trials
Abivax S.A.	19
FLS-RS	1
Orion Corporation, Orion Pharma	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	20
Other	1