A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Repair Capacity in Healthy Volunteers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinuvel Europe Limited

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2024-02-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Evaluate the impact of afamelanotide in aqueous solution on total UVR-induced direct DNA damage in healthy human skin.

Conditions and MedDRA coding

Healthy volunteers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Healthy adult males and females aged between 18 and 45 years (inclusive) (heart rate between 50 and 90 bpm, blood pressure below 120/80 mm Hg and above 90/60 mm Hg and normal renal and hepatic function as determined through laboratory testing)
2. Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator.
3. Free of significant abnormal findings as determined during the screening procedure by medical history, laboratory testing and vital signs.
4. Body Mass Index (BMI) between 18 and 30 kg/m2.
5. No history of drug abuse, licit or illicit assessed through medical history review and a urine drug screening test
6. Agree not to use any non-prescribed medications.
7. Willing to take precautions to prevent pregnancy with their partner.
8. Able and willing to follow the protocol requirements.
9. Able to understand and provide written Informed Consent prior to the performance of any study-specific procedure.

Exclusion criteria 13

1. Any personal or family history of melanoma or personal history of dysplastic nevus syndrome.
2. Regularly drinks more than four units of alcohol per day.
3. Participation in any clinical study during the six weeks before Screening.
4. Any significant illness prior to the study screening period.
5. Solarium use/sunbathing prior to study involvement and throughout the duration of the study.
6. Not suitable for study participation in the opinion of the Investigator.
7. Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure.
8. Any medical condition which may interfere with the study protocol.
9. Female who is pregnant or lactating.
10. Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
11. Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
12. Taking medications that are known photosensitisers.
13. Individual history of basal cell carcinoma, squamous cell carcinoma (inclusive carcinoma in situ e.g. Bowen’s disease), Merkel cell carcinoma or other malignant or premalignant skin lesions.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The changes in UV photoproducts from pre to post afamelanotide in UVR exposed skin and in non-irradiated skin.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinuvel Europe Limited

Sponsor organisation

Clinuvel Europe Limited

Address

Saint Kevins, 10 Earlsfort Terrace 10 Earlsfort Terrace

City

Dublin 2

Postcode

D02 T380

Country

Ireland

Scientific contact point

Organisation

Clinuvel Europe Limited

Contact name

Head of clinical operations

Public contact point

Organisation

Clinuvel Europe Limited

Contact name

Head of clinical operations

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 16 files

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

Application history

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