SAD and MAD Study of AKB-9090 in Healthy Adult Participants
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAkebia Therapeutics
About this trial
This is a first-in-human (FIH study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of AKB-9090 in healthy adult participants. The study consists of two stages: Stage 1, a single ascending dose (SAD) phase with five dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with three dose cohorts. Approximately 40 participants in SAD and 30 in MAD are planned to be enrolled.
Eligibility criteria
Qualifiers
Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and urinalysis).
Body mass index (BMI) greater than 18.5 and less than 32.0 kg/m² at screening.
In the Investigator's opinion, willing and able to provide written informed consent and comply with the all protocol requirements, including required confinement, outpatient visits, and protocol-specified restrictions (including refraining from major lifestyle changes) from signature of the informed consent form (ICF) through the last study visit.
Disqualifiers
Clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatologic, urogenital, ophthalmologic, ear/nose/throat, psychiatric, or neurologic disorder.
Treated basal cell carcinoma of the skin
Curatively resected squamous cell carcinoma of the skin
Treated colonic or cervical carcinoma in situ
Trial design
Treatments tested in this trial
- AKB-9090
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Akebia Therapeutics
Lead sponsor
Emerald Clinical Trials
Collaborator
Source ClinicalTrials.gov