Exploratory study on Azithromycin on senescence in healthy volunteers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

IRCCS Ospedale Policlinico San Martino

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Phenomena and Processes [G] - Physical Phenomena [G01], Phenomena and Processes [G] - Biological Phenomena [G16]

Decision date (initial)

2025-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Lunella Biotech

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

1) To compare the three study arms with AZI in terms of the selected marker of senescence

Secondary objectives 2

1. 1) To determine the minimum effective dose
2. 2) to examine the adverse events of AZI

Conditions and MedDRA coding

Cellular senescence and associated inflammatory status

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Age ≥ 60; ≤ 75 years
2. • Normal organ function (hepatic and renal)
3. • Established menopausal status for women (defined as no menses for 12 months)
4. • Written informed consent

Exclusion criteria 1

1. At least one of these: • Evidence of an ongoing acute inflammatory event • Infectious disease in progress • Inflammatory bowel disease • AIDS • Active neoplasms • Active hematological diseases • Autoimmune/rheumatologic diseases • Diabetes • Systemic therapy with anti-inflammatory drugs (NSAIDs, steroids, aspirin) during the 30 days preceding enrolment • Therapy with immunomodulatory drugs: infliximab, adalimumab, golimumab, or etanercept for 90 days preceding enrolment • Subjects with documented congenital or acquired QT interval prolongation • Therapy with active substances that prolong the QT interval • Disturbances in the balance of electrolytes in cases of hypokalaemia and hypomagnesemia • Clinically relevant bradycardia, cardiac arrhythmia, or severe heart failure • Known allergy to AZI • Other experimental therapies in progress • Previous infection with C. difficile • Patient have recieved an investigational drug within 30 days before screening or within five half-lives of the investigational product

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoints of this pilot study will be changes in 1) senescent cell abundance in the blood cells by p16INK4A evaluation; 2) other serum markers of aging/inflammaging

Secondary endpoints 2

1. To determine the minimum effective dose
2. To examine the safety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Ospedale Policlinico San Martino

Sponsor organisation

IRCCS Ospedale Policlinico San Martino

Address

Largo Rosanna Benzi 10

City

Genoa

Postcode

16132

Country

Italy

Scientific contact point

Organisation

IRCCS Ospedale Policlinico San Martino

Contact name

Alessio Nencioni

Public contact point

Organisation

IRCCS Ospedale Policlinico San Martino

Contact name

Alessio Nencioni

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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