MedTrace Logo

Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants

NCT06397508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-16

No results posted yet for this study

Summary

This is a single-center, open-label, single-dose, randomized, 3-period cross-over, Phase 1 study in healthy adult participants to assess the BA of AGMB-129 tablet formulation relative to that of the reference capsule formulation and to assess the effect of food on the BA of a single oral dose of the AGMB-129 tablet formulation.

A total of 24 participants will be enrolled. Participants will be randomized to 1 of 6 intervention sequences (Williams design) according to a 6-sequence, 3-period design. In 3 sequential intervention periods, each participant will receive 3 study interventions, 1 in each intervention period. The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AGMB-129

Each participant will receive 3 study interventions, 1 in each intervention period

Sponsors & Collaborators

  • Agomab Spain S.L.

    lead INDUSTRY

Principal Investigators

  • Philippe Wiesel, MD · Agomab Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2024-05-08
Completion
2024-05-13

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT06397508 on ClinicalTrials.gov