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To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers

NCT04908462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2022-10-14

No results posted yet for this study

Summary

The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Oral AL01211 in healthy volunteers

Conditions

  • Autosomal Dominant Polycystic Kidney

Interventions

DRUG

AL01211 or Placebo (Part A)

Five dose groups with doses ranging from 2mg to 60 mg

DRUG

AL01211 or Placebo (Part B)

Five dose groups with doses ranging from 2-60 mg daily. Each separate dose given for 14 days

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • AceLink Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, MBBS, FRACP · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Australia

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 NCT04908462 on ClinicalTrials.gov