Health Trials

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 four dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with one dose cohort. Approximately 32 participants in SAD and 12 in MAD are planned to be enrolled.

Eligibility criteria

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • AKB-9090

    Drug

    AKB-9090 will be administered intravenously

  • Placebo

    Other intervention

    Matching Placebo administered intravenously

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: AKB-9090Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs

Time frame
From First Dose to Day 7
2

Number of Participants with Clinically Significant Changes in Physical Examinations

Time frame
From First Dose to Day 7
3

Number of Participants with Clinically Significant Changes in Vital Signs

Time frame
From First Dose to Day 7
4

Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

Time frame
From First Dose to Day 7

Secondary outcomes

1

Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090

Time frame
At Day 1
2

Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090

Time frame
At Day 1
3

Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090

Time frame
At Day 1
4

Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090

Time frame
At Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akebia Therapeutics

Lead sponsor

Emerald Clinical Trials

Collaborator

Source ClinicalTrials.gov
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