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A SAD, MAD and Food Effect Study to Evaluate the Safety, Tolerability, PK, and PD of AJA001 in Healthy Subjects

NCT06019065 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-07-31

No results posted yet for this study

Summary

This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants. Food effect will be evaluated in one cross-over SAD fed dose cohort.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AJA001

AJA001

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • AJNA Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kristi McLendon, MD · Q-Pharm Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2024-03-26
Completion
2024-05-15
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019065 on ClinicalTrials.gov