NCT02868229|CompletedPhase 1ResultsDMCFDA Drug

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN6018-4791

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2016

StartedSep 2016

CompletionDec 2018

Brief Summary

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

August 9, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed

27 days until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

July 30, 2021

Completed

Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

August 9, 2016

Results QC Date

May 28, 2021

Last Update Submit

July 9, 2021

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

Characterization of Maximum Tolerated Dose (MTD)
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Weeks 0-24
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4
Change from the baseline in hsCRP values to week 4 are presented.
From baseline (mean of screening and day 1) to week 4
Change in Serum Amyloid A (SAA): Week 4
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
From baseline (mean of screening and day 1) to week 4

Secondary Outcomes (131)

Number of Adverse Events of Special Interest
Weeks 0-24
Number of Treatment Emergent Adverse Events (TEAEs)
Week 0-24
Electrocardiogram (ECG)
At baseline, week 6, week 12, week 18 and week 24
Number of Participants Who Developed Anti-drug Antibodies (ADAs)
Weeks 0-35
Number of Participants With ADA Titers
Weeks 0-35
+126 more secondary outcomes

Study Arms (2)

COR-001

EXPERIMENTAL

Drug: COR-001

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

COR-001DRUG

COR-001

PlaceboOTHER

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age greater than or equal to 18 years at the time of signing of the ICF.
The patient agrees to comply with the contraception and reproduction restrictions of the study
Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
At least 2 ferritin values during Screening \> 300 ng/mL
At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

You may not qualify if:

Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
Actively treated or active malignancy
Known or suspected occult or active bleeding
Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Contact the study team to confirm eligibility.