Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Safety

Outcome Measures

Primary Outcomes (22)

SAD: incidence of treatment emergent adverse events
Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam
Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram
Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests
Up to Day 8
MAD: incidence of treatment emergent adverse events
Up to Day 17

Secondary Outcomes (18)

SAD: time to reach Cmax (Tmax) of APX-115
Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115
Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)
Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115
Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115
Up to Day 5
+13 more secondary outcomes

Study Arms (7)

SAD: APX-115

EXPERIMENTAL

Experimental: APX-115 SAD group

Drug: SAD: APX-115

SAD: Placebo

PLACEBO COMPARATOR

Experimental: Placebo group

Drug: SAD: Placebo

MAD: APX-115

EXPERIMENTAL

Experimental: APX-115 MAD group

Drug: MAD: APX-115

Interventions

SAD: APX-115Drug

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

SAD: APX-115

SAD: PlaceboDrug

Drug: Placebo Placebo for 1day

SAD: Placebo

Eligibility Criteria

Age18 Years - 45 Years

Sexmale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male subject, aged between 18 and 45 years inclusive
Certified as healthy by a comprehensive clinical assessment

Sponsors & Collaborators

Aptabio Therapeutics, Inc.
Industrylead

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

MeSH Terms

Interventions

isuzinaxib

Study Officials

Yves Donazzolo, MD
Eurofins Optimed
PRINCIPAL INVESTIGATOR

Enrollment

88 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 3, 2018

Study Start

May 28, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (22)

Secondary Outcomes (18)

Study Arms (7)

SAD: APX-115

SAD: Placebo

MAD: APX-115

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

MAD: Placebo

Food effect - Fasting condition

Food effect - fed condition

Drug Interaction - metabolic probe

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (22)

Secondary Outcomes (18)

Study Arms (7)

SAD: APX-115

SAD: Placebo

MAD: APX-115

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

MAD: Placebo

Food effect - Fasting condition

Food effect - fed condition

Drug Interaction - metabolic probe

You may not qualify if:

Source record

Locations