Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

ATXA Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: NTP42:KVA4

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04919863

ATXA-CT001

Details and patient eligibility

About

A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.

Enrollment

79 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A body mass index (BMI) in the range 18.0-30.0.
Ability & willingness to provide written consent.

Exclusion criteria

Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
History of bleeding disorders, coagulation variables or abnormal blood cell count.
History of chronic illness.
Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
History of adverse reaction or allergy to any drug.
Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
History of drug or alcohol abuse
Smoker or use of nicotine-containing products
Blood pressure or heart rate at screening outside normal ranges.