NCT04589403

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Op-T LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	OPT101	15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2020-10-19
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study