NCT05937386

CompletedPhase 1

Drug-Drug Interaction Study With AGMB-129 and Midazolam in H...

Agomab Spain S.L.Source

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Other study identifiers

Sponsor study identifier

AGMB-129-C104

Study Type

interventional

Actual enrollment (reported)

14

Locations

1 country

Sites

1

Timeline

Study Start

August 9, 2023

Actual (reported)

Primary Completion

September 6, 2023

Actual (reported)

Study Completion

September 6, 2023

Actual (reported)

Brief Summary

This is a single-center, open-label, fixed-sequence, Phase 1 study in healthy adult participants to evaluate the effect of AGMB-129 on the PK of a single dose of MDZ in healthy participants. A total of 14 participants will be enrolled and will receive study intervention in a fixed-sequence scheme. All IP will be administered orally and in fed conditions. The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 14 participants
Study completion date: September 6, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 30, 2023
Actual (reported)
First Posted
July 10, 2023
Actual (reported)
Study Start
August 9, 2023
Actual (reported)
Primary Completion
September 6, 2023
Actual (reported)
Study Completion
September 6, 2023
Actual (reported)

Last Updated: June 18, 2024
Status Verified: June 2024
Last Update Submitted: June 17, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

Cmax for MDZ
Day 1 to Day 13
Cmax for 1-OH-midazolam
Day 1 to Day 13
AUC0-∞ for MDZ
Day 1 to Day 13
AUC0-∞ for 1-OH-midazolam
Day 1 to Day 13

Secondary Outcomes (13)

Cmax for AGMB-129
Day 3 to Day 14
Cmax for MET-154
Day 3 to Day 14
Cmax for MET-158
Day 3 to Day 14
AUC0-t for AGMB-129
Day 3 to Day 14
AUC0-t for MET-154
Day 3 to Day 14
+8 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

AGMB-129 and MDZ

Drug: AGMB-129Drug: MDZ

Interventions

AGMB-129Drug

Oral capsule

1

MDZDrug

Pre-filled oral syringes

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female, between 18 and 55 years old (extremes included) on the date of signing the ICF.
Body weight of at least 50.0 kg for men and 45.0 kg for women, and a body mass index (BMI) between 19.0 and 30.0 kg/m2 (extremes included) at screening.

Sponsors & Collaborators

Agomab Spain S.L.
Industrylead

Study Sites (1)

SGS Belgium

Edegem, Belgium

Study Officials

Philippe Wiesel, MD
Agomab Therapeutics
STUDY DIRECTOR

Enrollment

14 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 10, 2023

Study Start

August 9, 2023

Actual (reported)

Primary Completion

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Must be in good health based on medical history, physical examination, vital signs, and 12-lead ECG in the opinion of the investigator at screening.

Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be ≤1.5x upper limit of normal (ULN) at screening. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator. Note: Participants with diagnosed Gilbert's syndrome with total bilirubin \>1.5 ULN are eligible for the study if AST and ALT are ≤1.5x ULN.

You may not qualify if:

Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
Positive serology for hepatitis B virus surface antigen (HBsAg) or anti-hepatitis C virus \[HCV\] antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first IP administration.
History of or a current immunosuppressive condition, including positive human immunodeficiency virus types 1 or 2 (HIV-1 \[2\]) antibodies at screening.
Current or history of vasculitis, valvular heart disease, or large vessel vascular disease (such as aneurism or dissection) at screening.
Any illness, judged by the investigator as clinically significant, in the 3 months prior to the first IP administration.
Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate \[eGFR\] ≤80 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening.
History of malignancy within the past 5 years prior to screening, except for excised and curatively treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of cervix which is considered cured with minimal risk of recurrence.
History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction, e.g., known long QT syndrome or a QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 ms detected on the 12-lead ECG at screening or Day 1 predose. A first-degree atrioventricular block will not be considered as a clinically significant abnormality.

Contact the study team to confirm eligibility.

September 6, 2023

Actual (reported)

Study Completion

September 6, 2023

Actual (reported)

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05937386
Data provider: ClinicalTrials.gov
Source updated: 2024-06-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:25 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (13)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations