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A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects

NCT03935568 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-18

No results posted yet for this study

Summary

This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.

Conditions

Interventions

DRUG

PU-AD

3 cohorts receiving a single oral dose of PU-AD at one time.

DRUG

Placebo

3 cohorts receiving a single oral dose of Placebo at one time

DRUG

Placebo

2 cohorts receiving multiple oral dose of Placebo at one time

DRUG

PU-AD

2 cohorts receiving multiple oral dose of PU-AD at one time

Sponsors & Collaborators

  • Samus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael H Silverman, M.D. · Samus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2019-12-23
Completion
2019-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03935568 on ClinicalTrials.gov