A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous in Healthy Volunteers

NCT04321980 | Completed Phase 1 Results DMC

• 1 other identifier: OP-101-003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After Subcutaneous Administration in Healthy Volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events

  An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. A TEAE (treatment-emergent adverse event) was defined as an AE that emerges, having been absent prior to the study, or an AE that worsens in severity after the first dose of the study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes: death; life-threatening adverse event, required hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, or a medically important event.

  Up to Day 15

Secondary Outcomes (5)

• Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of OP-101

  Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose

• Pharmacokinetics: Time to Reach Maximum Plasma Concentration (Tmax) of OP-101

  Pre-dose, 0.5 hours and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of OP-101

  Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to 48 Hour Post Dose Time Point (AUC0-48) of OP-101

  Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose

• Pharmacokinetics: Renal Clearance (CLR) for OP-101

  Pre-dose, 0 to 4, 4 to 8, 8 to 12, 12 to 18, 18 to 24, and 24 to 48 hours post dose

Study Arms (2)

Cohort 1

EXPERIMENTAL

Subjects in Cohort 1 will be administered 4 mg/kg OP-101 as a subcutaneous (SC) injection.

Drug: OP-101

Cohort 2

EXPERIMENTAL

Subjects in Cohort 2 will be administered 8 mg/kg OP-101 as a SC injection.

Drug: OP-101

Interventions

OP-101 DRUG

Subcutaneous injection of OP-101 in healthy volunteers

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit;
• Has the ability to understand and sign the written Informed Consent Form (ICF) and local medical privacy authorization forms, which must be obtained prior to any study related procedures being completed;
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
• Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator;
• Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges;
• Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male subjects must use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 30 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
• Acceptable methods of contraception for male subjects enrolled in the study include the following:
• Condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (vasectomy);
• Acceptable methods of contraception for female subjects enrolled in the study include the following:
• Surgical sterilization of subject at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, oophorectomy, or salpingectomy);
• Intrauterine device for at least 12 weeks before the Screening Visit;
• Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit; or
• Diaphragm;
• If male, subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of study drug;
• Female subjects may not be pregnant, lactating, or breastfeeding;

You may not qualify if:

• Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study;
• History of malignancy (other than successfully treated basal cell or squamous cell skin cancer);
• History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant;
• Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening;
• History of alcoholism or drug abuse within 2 years prior to screening;
• Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study;
• Has had any immunizations (live vaccines) in the 4 weeks prior to screening;
• Has used medications that affect GI motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day 1;
• Has used any prescription or over-the-counter medication (with exception of acetaminophen), vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1;
• Has used any other study drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Day 1;
• Has lost or donated \>450 mL of whole blood or blood products within 30 days prior to screening;
• Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements;
• Has any finding that, in the view of the Investigator or Medical Monitor, would compromise the subject's safety requirements; or
• Is employed by the Sponsor, the Contract Research Organization (CRO), or the study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, CRO, or study site employee.

Sponsors & Collaborators

• Orpheris, Inc.: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Results Point of Contact

• Title: Jeffrey L Cleland, PhD, Executive Chair
• Organization: Orpheris, Inc.

cleland@orpheris.com

650-505-5048

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: March 19, 2020
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)