Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

May 28, 2018

Primary Completion Date

March 6, 2019

Study Completion Date

March 6, 2019

Conditions
HealthySafety
Interventions
DRUG

SAD: APX-115

Drug: APX-115 SAD APX-115 SAD for 1day

DRUG

SAD: Placebo

Drug: Placebo Placebo for 1day

DRUG

MAD: APX-115

Drug: APX-115 MAD APX-115 MAD repeatedly administered.

DRUG

MAD: Placebo

Matching study drug will be repeatedly administered.

OTHER

Food effect: fasted and fed

A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.

OTHER

Metabolic probe with or without APX-115

A metabolic probe will be administered with and without APX-115.

Trial Locations (1)

38610

Eurofins Optimed, Gières

Sponsors
All Listed Sponsors
lead

Aptabio Therapeutics, Inc.

INDIV