A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211

AceLink Therapeutics, Inc.1 site in 1 country69 target enrollmentJune 8, 2021

ConditionsAutosomal Dominant Polycystic Kidney

InterventionsAL01211 or Placebo (Part A)AL01211 or Placebo (Part B)

Overview

Phase: Phase 1
Intervention: AL01211 or Placebo (Part A)
Conditions: Autosomal Dominant Polycystic Kidney
Sponsor: AceLink Therapeutics, Inc.
Enrollment: 69
Locations: 1
Primary Endpoint: To assess the safety and tolerability measures of AL01211 through Adverse Events/Serious Adverse Events in healthy adult participants
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

This study is a Phase 1, first in human (FIH), randomized, double-blind, placebo-controlled study of AL01211 in healthy adult participants The study consists of two parts: Part A will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL01211 in a single ascending dose escalation study in approximately 40 healthy adult participants. Part B will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of AL01211 in a multiple ascending dose escalation study in approximately 40 healthy adult volunteers.

Registry

clinicaltrials.gov

Start Date

June 8, 2021

End Date

June 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

AceLink Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Part A (SAD) and Part B (MAD)
•To be eligible for the study, participants must meet all of the following inclusion criteria:
•Healthy male or female volunteers, between 18 and 55 years of age
•Participants in good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory tests.
•Body Mass Index (BMI) between 20.0 and 34.9 kg/m2 (inclusive).
•Participants who smoke no more than 2 cigarettes per day or equivalent per week (includes e-cigarettes) can be included in the study but must be willing to abstain from smoking during confinement periods.
•Participants must have no relevant dietary restrictions,
•Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until at least 30 days have passed since study drug administration , including the follow-up period. Double contraception is defined as a condom AND one other form of the following:
•Established hormonal contraception (oral contraceptive pills \[OCPs\], long-acting implantable hormones, and injectable hormones) for at least 1 month prior to Screening
•A vaginal ring or an intrauterine device \[IUD\]

Exclusion Criteria

•For Part A (SAD) and Part B (MAD)
•A participant who meets any of the following exclusion criteria must be excluded from the study:
•Any concomitant disease, condition, or treatment that could interfere with the conduct of the study,.
•History or symptoms of significant psychiatric disease,
•History or evidence of significant hepatic or renal disease or impairment, including clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel and liver function tests, and urinalysis).
•Evidence of an active or suspected cancer or a history of malignancy for at least 5 years, except for: nonmelanoma skin cancer considered cured, curatively treated localized prostate cancer, or other in situ cancer.
•Known hypersensitivity or allergy to AL01211 or excipient contained in the drug formulation.
•Uncontrolled hypertension of \> 140/90 mm Hg despite optimal therapy.
•Any of the following abnormal ECG findings at Screening:
•PR interval \> 210 ms or \< 120 ms

Arms & Interventions

Part A Healthy volunteers: Single ascending doses

Intervention: AL01211 or Placebo (Part A)

Part B Healthy Volunteers Multiple ascending doses

Intervention: AL01211 or Placebo (Part B)

Outcomes

Primary Outcomes

To assess the safety and tolerability measures of AL01211 through Adverse Events/Serious Adverse Events in healthy adult participants

Time Frame: Baseline to End of the Treatment assessed up to an average of 90 days

Number of participants with treatment related adverse events as assessed through CTCAE v5.0

Secondary Outcomes

To assess the pharmacokinetics of AL01211 in healthy adult participants(Baseline to End of the Treatment assessed up to an average of 56 days)
Measurement of glucosylceramide in plasma and urine following oral dosing of AL01211(Baseline to End of the Treatment assessed up to an average of 56 days)
Measurement of monosialodihexosylganglioside in plasma and urine following oral dosing of AL01211(Baseline to End of the Treatment assessed up to an average of 56 days)