HealthyPhase 1NCT04321980

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

A Phase 1 study testing OP-101 in people with Healthy, run by Orpheris, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: OP-101
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteAustralia
Study dates: 19 Mar 2020to 22 May 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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;
Female subjects of childbearing potential must have negative result for pregnancy test at screening and Check-in;
Subjects must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVab), and human immunodeficiency virus (HIV) antibody at screening;
Subjects must have an estimated glomerular filtration rate (eGFR) of ≥90 mL/min/1.73m2 at screening;
Subjects must have a negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, and phencyclidine), cotinine, and breath alcohol test at screening and Check-in; and
Subjects must be willing and able to abide by all study requirements and restrictions.

Who cannot join

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;
Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) above the upper limit of normal at screening and/or Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
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;

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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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-acetyl-cysteine) After Subcutaneous Administration in Healthy Volunteers

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

Conditions: Healthy
Being tested: OP-101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OP-101Drug
Subcutaneous injection of OP-101 in healthy volunteers

Study groups in NCT04321980
Study group	Role	What they receive
Cohort 1	Experimental	Subjects in Cohort 1 will be administered 4 mg/kg OP-101 as a subcutaneous (SC) injection. Receives: Drug: OP-101
Cohort 2	Experimental	Subjects in Cohort 2 will be administered 8 mg/kg OP-101 as a SC injection. Receives: Drug: OP-101

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 15

Secondary outcomes (5)

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of OP-101
Cmax: maximum observed plasma concentration.
Measured: 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
Tmax: time to reach maximum observed plasma concentration.
Measured: 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
AUC0-last: Area under the concentration versus time curve from time zero to the last quantifiable concentration (Clast).
Measured: 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
Area under the concentration versus time curve from time zero to 48 hour post dose time point.
Measured: 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
CLR was defined as renal clearance of the drug from plasma utilizing the AUC and cumulative amount of unchanged study drug excreted into the urine (Ae) to the same duration (as Amount recovered/AUC at 0-48 hours).
Measured: Pre-dose, 0 to 4, 4 to 8, 8 to 12, 12 to 18, 18 to 24, and 24 to 48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202022 May 2020

First posted26 Mar 2020
Study start19 Mar 2020
Primary completion22 May 2020
Study completion22 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04321980
Sponsor's protocol ID: OP-101-003
Status last verified: May 2021
First submitted: 23 Mar 2020
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-acetyl-cysteine) After Subcutaneous Administration in Healthy Volunteers
ClinicalTrials.gov ID: NCT04321980
Acronym / sponsor ID: OP-101-003
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Orpheris, Inc.Industry (pharma, biotech, devices)
Study start: 19 Mar 2020 (actual)
Primary completion: 22 May 2020 (actual)
Study completion: 22 May 2020 (actual)
First posted: 26 Mar 2020 (actual)
Results: Posted 14 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: OP-101Subjects in Cohort 1 will be administered 4 mg/kg OP-101 as a subcutaneous (SC) injection.
Cohort 2	Experimental	Drug: OP-101Subjects in Cohort 2 will be administered 8 mg/kg OP-101 as a SC injection.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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;

Key exclusion criteria (15 listed)

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;
Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) above the upper limit of normal at screening and/or Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OP-101Subcutaneous injection of OP-101 in healthy volunteers	Drug	Cohort 1, Cohort 2

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Time frame: Up to Day 15
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.

5 secondary outcomes

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of OP-101
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose, 0 to 4, 4 to 8, 8 to 12, 12 to 18, 18 to 24, and 24 to 48 hours post dose

Results and safety

Results posted to the registry on 14 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: 4 mg/kg	4	4
Cohort 2: 8 mg/kg	4	4

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events

Time frame: Up to Day 15. Count of participants. Unit: Participants

Measure	Cohort 1: 4 mg/kg n = 4	Cohort 2: 8 mg/kg n = 4
Any TEAE	2	3
Any SAE	0	0

Population analysed: Analysis was performed on safety population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 15. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 4 mg/kg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Cohort 2: 8 mg/kg	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OP-101 in people with Healthy, run by Orpheris, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (time frame: Up to Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.