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

Healthy Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

2 part study description: • an initial Phase 1a single ascending dose (SAD) phase to identify a safe dose of OPT101. Dose escalation will be by a factor of 2.6: 0.16, 0.42, 1.1, 2.8 and 7.3mg/kg. • a Phase 1b multiple ascending dose (MAD) phase to measure safety and clinical effects of the highest and next to highest dose of OPT101 that are found to be safe in Phase 1a. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04589403
Study type Interventional
Source Op-T LLC
Contact Charlie Henry
Phone 303-570-8623
Email cwh@op-t.com
Status Recruiting
Phase Phase 1
Start date February 18, 2021
Completion date June 30, 2024
View Details
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