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

NCT04589403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-15

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

OPT101

15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40

Sponsors & Collaborators

  • Op-T LLC

    lead INDUSTRY

Principal Investigators

  • Isaac Melamed, MD · IMMUNOe Health Centers

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-09-27
Completion
2021-09-27
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 NCT04589403 on ClinicalTrials.gov