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

NCT04589403 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: OPT-100-30
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Incidence of abnormal vital signs and abnormal laboratory values

  21 days

• Rate and type of adverse events during and after infusion of OPT101 or placebo

  Collection of all adverse events

  48 hours

• Incidence of vital signs

  Continuous telemetry monitoring

  48 hours

• Incidence of abnormal laboratory values

  Blood laboratory results and iStat results onsite

  21 days

• Definition of maximum tolerated (MTD) single and repeated doses of OPT101

  DMC and Safety and Tolerability

  48 hours

Secondary Outcomes (2)

• Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)

  8 hours

• Development of anti-drug antibodies after 1 or more infusions

  2 weeks- 1 prior to infusion and day 15

Study Arms (2)

0.9% Sodium Chloride Injection USP

PLACEBO COMPARATOR

Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes.

Drug: OPT101

OPT101

EXPERIMENTAL

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.

Drug: OPT101

Interventions

OPT101 DRUG

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

Also known as: 15-mer peptide

0.9% Sodium Chloride Injection USP; OPT101

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Is over the age of 55 years old
• Positive COVID test at screening/baseline
• Has an active fever or has recently been exposed to a COVID-19 patient.
• Currently has or had a history of malignancy
• Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
• Is currently being treated for an autoimmune disease/s
• Subjects with a history of venous and arterial thromboembolic events including, but not limited to, the following: deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene should be excluded. In addition, subjects with recent immobilization or recent surgery, should be excluded. Subjects with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome should also be excluded.
• Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV) chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
• Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody \[anti-HBs\]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) may be eligible to participate.
• Has history of immune suppression disorders
• Has received a live (attenuated) vaccine within the last 60 days, including subjects who plan to receive live (attenuated) vaccines during the study or within 60 days after the final dose of study treatment.
• Has received influenza vaccine within 14 days of screening.
• Has received a biologic or immunotherapy in the last 6 months (If receiving allergy shots with stable dosing, is acceptable)
• Has received prescription or non-prescription medication and in the opinion of the Investigator, the product will interfere with the study procedures or data integrity or compromise the safety of the subject.
• Subjects with clinically significant abnormal laboratory test values in screening blood samples. In particular subjects with the following should be excluded:

Sponsors & Collaborators

• Op-T LLC: lead

Study Sites (1)

IMMUNOe Research

Centennial, Colorado, 80112, United States

Location

Study Officials

• Isaac Melamed, MD

  IMMUNOe Health Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Pharmacist will be the only unmasked clinical staff as the preparer of the investigational product prior to infusion.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sentinel dosing of two subjects followed by review of the data by the Data Monitoring Committee (DMC) will be performed prior to enrolling any additional subjects within a cohort. Groups of 3 subjects (2 active:1 placebo) each will be treated at each dose level; for a total of 15 subjects. Additional subjects may be added to any cohort if dose limiting toxicity (DLT) is observed for a maximum of up to 6 subjects per cohort. An additional 6 subjects may also be enrolled in an intermediate dose cohort between the dose level which exceeds the defined MTD and the previous defined dose level.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: February 18, 2021
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)