A study to evaluate the safety and tolerability of single ascending doses of AGMB-101 in healthy participants (Part A) and patients with liver cirrhosis (Part B).

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol AGMB101-01-CL-102

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 64

Countries 1

Sites 1

liver cirrhosis

Key facts

Sponsor: AgomAb Therapeutics
Participant type: Patients, Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Decision date (initial): 2025-02-21
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

liver cirrhosis

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AgomAb Therapeutics

Sponsor organisation: AgomAb Therapeutics
Address: Posthoflei 1/6
City: Antwerp
Postcode: 2600
Country: Belgium

Scientific contact point

Organisation: AgomAb Therapeutics
Contact name: Clinical Operations

Public contact point

Organisation: AgomAb Therapeutics
Contact name: Clinical Operations

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Authorised, recruitment pending	64	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Authorised, recruitment pending

SGS Belgium

SGS-Clinical Research CPU, Drie Eikenstraat 655, 2650, Edegem

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-27	Belgium	Acceptable 2025-02-19	2025-02-21
2	SUBSTANTIAL MODIFICATION	SM-1	2025-02-24	Belgium	Acceptable	2025-02-27