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SAD and MAD Study of AKB-9090 in Healthy Adult Participants

NCT07429006 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AKB-9090

AKB-9090 will be administered intravenously

OTHER

Placebo

Matching Placebo administered intravenously

Sponsors & Collaborators

  • Emerald Clinical Trials

    collaborator UNKNOWN

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429006 on ClinicalTrials.gov