ABX464 First in Man Study

Status Completed

Clinical Trial Summary

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

Clinical Trial Description

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs) ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT02792686
Study type	Interventional
Source	Abivax S.A.
Contact
Status	Completed
Phase	Phase 1
Start date	March 2014
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05001152` - Taste Assessment of Ozanimod	Phase 1
Completed	`NCT05029518` - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability	Phase 1
Completed	`NCT04493255` - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants	Phase 1
Completed	`NCT03457649` - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers	Phase 1
Completed	`NCT00995891` - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed	`NCT05050318` - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively	Phase 4
Completed	`NCT05043766` - Evaluation of Oral PF614 Relative to OxyContin	Phase 1
Completed	`NCT04466748` - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects	Phase 1
Completed	`NCT00746733` - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Phase 1
Recruiting	`NCT05929651` - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy	Phase 4
Completed	`NCT05954039` - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect	N/A
Completed	`NCT05045716` - A Study of Subcutaneous Lecanemab in Healthy Participants	Phase 1
Active, not recruiting	`NCT02747927` - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children	Phase 3
Completed	`NCT05533801` - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants	Phase 1
Not yet recruiting	`NCT03931369` - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)	Phase 2
Completed	`NCT03279146` - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects	Phase 1
Completed	`NCT06027437` - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants	Phase 1
Recruiting	`NCT05619874` - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity	N/A
Completed	`NCT05553418` - Investigational On-body Injector Clinical Study	N/A
Completed	`NCT04092712` - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers	Phase 1