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Single Ascending Dose Study of ALA-1000

NCT04122755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-12-30

No results posted yet for this study

Summary

An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

ALA-1000

Blood sample for PK analysis are collected before and post single injection of ALA-1000 (Day1) according to the schedule of procedures. Subjects remain in the residential phase through Day21 for safety assessment.

DRUG

buprenorphine sublingual film

ALA-1000 injection after 7 days of buprenorphine sublingual film dosing. Blood sample for PK analysis are collected before and post sublingual buprenorphine dosing on Day-1

Sponsors & Collaborators

  • Alar Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Erin Tireman · Innovative Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2021-05-03
Completion
2021-05-03
FDA Drug
Yes

Countries

  • United States

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 NCT04122755 on ClinicalTrials.gov