Phase 1 Study of CLIP-100 in Healthy Adults
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous CLIP-100 in Healthy Adults
Amalfi Bio, Inc
25 participants
May 5, 2026
Interventional
Conditions
Summary
This study is being conducted to evaluate the safety, tolerability, and pharmacokinetic profile of single escalating doses of CLIP-100 administered as an injectable lipolysis agent into the subcutaneous abdominal fat of healthy adult participants. Up to 25 healthy participants with subcutaneous fat in the abdominal region will be enrolled in five escalating dose cohorts.
Eligibility
Inclusion Criteria3
- Participant must be 18 to 64 years of age inclusive, at the time of signing the informed consent
- Participants who are overtly healthy as determined by medical evaluations including medical history, physician examination, vital signs, laboratory tests and cardiac monitoring.
- Body weight greater than or equal to 50 kg at screening and Day -1 and a body mass index (BMI) within the range, greater than 18.5 and less than 32 kg/m².
Exclusion Criteria9
- Clinically significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the trial intervention; or interfering with the data
- Abnormal skin or local skin condition in the abdominal region
- Current or chronic history of liver disease.
- On prescription or over the counter (OTC) weight reduction medication, weight reduction programs, or taking oral/injectable GLP-1 agonists
- Unable to receive local anaesthesia or hypersensitivity to lidocaine.
- Current enrolment or past participation in another investigational trial in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered withing 90 days before signing consent in this clinical trial
- Participants with fever or any acute infection within 28 days of screening and throughout Day 1
- Previous surgery which caused scarring in the abdominal region
- Prior history of any aesthetic procedures to the abdominal region, including liposuction, tattoos, injectable products, poly-l-lactic acid, etc.
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Interventions
This is a dose-escalation study evaluating five single ascending dose cohorts of CLIP-100 (60mg, 120mg, 240mg, 300mg, 400mg). A single dose will be administered by subcutaneous injection into the abdominal adipose tissue by clinical staff at the Phase 1 facility under direct medical supervision. Progression to each subsequent cohort requires review of available safety, tolerability and PK data through at least Day 8 by the Safety Monitoring Committee. Adherence is confirmed by direct observation of injection administration and documentation at the Phase 1 facility. PK sampling throughout the study period provides objective confirmation of drug exposure.
Locations(1)
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ACTRN12626000483358