Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT04589403
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.
Sponsor:
Op-T LLC
Organization:
Study Overview
Official Title:
A Phase 1a/1b Study of OPT101 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
• 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: