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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: OPT101

• Registration Number: NCT04589403
• Lead Sponsor: Op-T LLC

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.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2021-02-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Sodium Chloride Injection USP	OPT101	Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes.
OPT101	OPT101	The starting dose for the Phase 1a study is 0.16 mg/kg, which is 35-fold lower than the dog NOAEL (10mg/kg), on a mg/m2 basis. The dosing frequency for the MAD study was selected based on dosing performed in the supporting animal model studies. For an additional safety factor, the dose and volume infusion rates for the 0.16 mg/kg dose in humans will be 67-fold and 14-fold lower than the dogs dosed at 10mg/kg/min and mL/kg/min basis, respectively. For both Phase 1a and 1b, OPT101 will be administered by a slow IV infusion over 30 minutes.

Primary Outcome Measures

Name	Time	Method
Incidence of abnormal laboratory values	21 days	Blood laboratory results and iStat results onsite
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	21 days	Incidence of abnormal vital signs and abnormal laboratory values
Incidence of vital signs	48 hours	Continuous telemetry monitoring
Rate and type of adverse events during and after infusion of OPT101 or placebo	48 hours	Collection of all adverse events
Definition of maximum tolerated (MTD) single and repeated doses of OPT101	48 hours	DMC and Safety and Tolerability

Secondary Outcome Measures

Name	Time	Method
Development of anti-drug antibodies after 1 or more infusions	2 weeks- 1 prior to infusion and day 15	Anti-drug antibodies will be collected 2 times during study
Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)	8 hours	PK samples will be taken at 8 time points during the infusion

Trial Locations

Locations (1)

IMMUNOe Research; 🇺🇸 Centennial, Colorado, United States