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Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects

NCT04104399 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-09-23

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.

Conditions

Interventions

DRUG

XC101-D13H

XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules

DRUG

Placebo

Placebo supplied as matching capsules

Sponsors & Collaborators

  • Xoc Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Robert Fishman, MD · Xoc Consulting Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2022-01-28
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04104399 on ClinicalTrials.gov