A Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics and Safety of ANT3310 Combined with Meropenem Administered as a Single Intravenous Infusion to Adult Subjects with Renal Function Impairment

Start 19 Jul 2024 · End 10 Jul 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol ANT3310-SP-002-V01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 48

Countries 1

Sites 1

Renal impairment

Key facts

Sponsor: Antabio
Participant type: Healthy volunteers, Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration: 19 Jul 2024 → 10 Jul 2025
Decision date (initial): 2024-06-12
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

Renal impairment

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antabio

Sponsor organisation: Antabio
Address: Biostep, 436 Rue Pierre Et Marie Curie 436 Rue Pierre Et Marie Curie
City: Labege
Postcode: 31670
Country: France

Scientific contact point

Organisation: Antabio
Contact name: Clinical department

Public contact point

Organisation: Antabio
Contact name: Clinical department

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	48	1
Rest of world	—	0	—

Investigational sites

Germany

1 site · Ended

CRS Clinical Research Services Management GmbH

Clinic, Lornsenstrasse 7, Brunswik, Kiel

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2024-07-19	2025-07-10	2024-07-19	2025-06-24

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-05-03	Germany	Acceptable 2024-05-27	2024-06-12
2	SUBSTANTIAL MODIFICATION	SM-1	2024-10-10	Germany	Acceptable 2024-11-05	2024-11-06
3	SUBSTANTIAL MODIFICATION	SM-2	2025-02-18	Germany	Acceptable 2025-03-12	2025-03-13
4	SUBSTANTIAL MODIFICATION	SM-3	2025-04-23	Germany	Acceptable 2025-05-19	2025-05-20