Safety, Tolerability, and Imaging Quality of HarMono-T Contrast Agent During Ultrasound of the Kidney in Healthy Subjects

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Solstice Pharmaceuticals B.V.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-08-12

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: Safety, Diagnosis

To evaluate the safety and tolerability of four different single intravenous (IV) doses of HarMono-T microbubbles in healthy subjects.

Secondary objectives 4

1. To determine the optimal dose range of the HarMono-T contrast agent.
2. To determine the wash-in and wash-out parameters for the kidney.
3. To determine the ratio between dose and contrast agent enrichment.
4. To evaluate the total clearance of Har-Mono-T after 30minutes

Conditions and MedDRA coding

Ultrasound contrast agent, for diagnostic purposes (to assess indeterminate kidney lesions)

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Subject provides written informed consent and is willing to comply with protocol requirements.
2. Subject is at least 18 years of age
3. Subject is in good health determined by no clinically significant findings from medical history, physical examination, clinical laboratory data, vital sign measurements and the 12-lead ECG

Exclusion criteria 8

1. Subject is older than 50 years of age, as below the age of 50 there is the least risk of subjects having underlying (kidney) problems or other comorbidities
2. Subject is receiving any other contrast medium, within 48hours before and up to 24 hours following the administration of HarMono-T
3. Subject has any known allergy to one or more of the ingredients of the investigational product (per-flutren (C3F8) gas or to any other components of HarMono-T)
4. Subject has any contraindication to the planned imaging procedure (ultrasound) e.g., implants, inadequate medical conditions etc
5. Subject has received an investigational compound within 30days before admission into this study
6. Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objec-tives, or completing the study and/or post-dose follow-up examinations
7. Subject is determined by the Investigator that the subject is clinically unsuitable for the study
8. Subject is a pregnant or lactating female. Exclude the possibility of pregnancy by: o Testing on site at the institution with a rapid pregnancy test within 24 hours prior to the start of HarMono-T administration, o Surgical history (e.g., tubal ligation or hysterectomy), o Post-menopausal with a minimum one year without menses. o Peri-Menopausal (menopausal for less than 1 year)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. The occurrence of adverse reactions until 7±2days post injection
2. 12-lead ECG
3. Vital signs
4. Clinical laboratory parameters (haematology; renal and hepatic functions)

Secondary endpoints 4

1. Parametric imaging (Time to Peak (s), Peak Enhance-ment (dB))
2. Parametric imaging (Wash-in Area Under the Curve (dB), Wash-out Area Under the Curve (dB))
3. Parametric imaging (Peak Enhancement (dB))
4. CEUS at 30minutes post dose is to confirm total clearing of HarMono-T

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Solstice Pharmaceuticals B.V.

Sponsor organisation

Solstice Pharmaceuticals B.V.

Address

Josink Esweg 36

City

Enschede

Postcode

7545 PN

Country

Netherlands

Scientific contact point

Organisation

Solstice Pharmaceuticals B.V.

Contact name

Wim van Hoeve

Public contact point

Organisation

Solstice Pharmaceuticals B.V.

Contact name

Wim van Hoeve

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 9 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