CelluJuve Injections for Healthy Volunteers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spiderwort Biotechnologies Inc.

Must not be taking: Anticoagulants, Immunomodulating therapy

Disqualifiers: Pregnancy, Skin disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must adhere to medication restrictions during the study. It's best to discuss your specific medications with the study team.

Are You a Good Fit for This Trial?

Healthy adults aged 30-65, with healthy skin on their non-dominant arm, can join this trial. Women must not be pregnant or breastfeeding and use reliable contraception. People are excluded if they have a history of severe allergies to CelluJuve® components, keloid scarring, significant health conditions that could affect the study or are taking certain medications.

Inclusion Criteria

Signed ICF and Photographic Release

I am between 30 and 65 years old and in good health.

I am a woman who can have children, have a negative pregnancy test, and use birth control.

Exclusion Criteria

Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse)

Known history or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity

Known history of medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of CelluJuve® into the proximal medial aspect of the brachium

1 day

1 visit (in-person)

Biopsy and Analysis

Punch biopsies are taken at 2 weeks, 1 month, and 3 months for histological analysis

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CelluJuve®

Trial Overview The trial is testing CelluJuve®, an injectable treatment administered into the upper arm's skin. Participants will receive microbolus injections in one arm and undergo a small biopsy to assess safety and changes in tissue structure.

How Is the Trial Designed?

Group I: CelluJuve® Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Spiderwort Biotechnologies Inc.

Lead Sponsor

ethica Clinical Research Inc.

Industry Sponsor

Trials

20

Recruited

1,800+