COMPLETED

1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.

Official Title

A Phase 1a/1b Study of OPT101 in Healthy Volunteers

Quick Facts

Study Start:2021-02-18
Study Completion:2021-09-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04589403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Isaac Melamed, MD
PRINCIPAL_INVESTIGATOR
IMMUNOe Health Centers

Study Locations (Sites)

IMMUNOe Research
Centennial, Colorado, 80112
United States

Collaborators and Investigators

Sponsor: Op-T LLC

  • Isaac Melamed, MD, PRINCIPAL_INVESTIGATOR, IMMUNOe Health Centers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-18
Study Completion Date2021-09-27

Study Record Updates

Study Start Date2021-02-18
Study Completion Date2021-09-27

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy