NCT03133676

Brief Summary

This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2018

Typical duration for phase_1

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

April 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 17, 2021

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

April 20, 2017

Results QC Date

April 23, 2021

Last Update Submit

December 22, 2022

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisArthritisJoint DiseaseOsteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)

    TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.

    Day 1 up to Day 29

  • MAD Part: Number of Subjects Who Experienced TEAEs

    TEAEs were collected from time of first administration of IP (Day 1) until 30 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the CTCAE version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, SAEs, related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.

    Day 1 up to Day 180

Secondary Outcomes (28)

  • SAD Part: Mean Change From Baseline in Hemoglobin at Day 8

    Baseline and Day 8

  • MAD Part: Mean Change From Baseline in Hemoglobin at Day 180

    Baseline and Day 180

  • SAD Part: Mean Change From Baseline in Hematocrit at Day 8

    Baseline and Day 8

  • MAD Part: Mean Change From Baseline in Hematocrit at Day 180

    Baseline and Day 180

  • SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8

    Baseline and Day 8

  • +23 more secondary outcomes

Study Arms (2)

KA34 Active Drug

EXPERIMENTAL

KA34 active drug in the dose range of 50 - 400 ug per knee

Drug: KA34

Placebo

PLACEBO COMPARATOR

Placebo is the formulation for KA34.

Drug: Placebo

Interventions

KA34DRUG

50 µg - 400 µg intra-articular injection (single or multiple doses)

Also known as: KA-34
KA34 Active Drug
PlaceboDRUG

50 µg - 400 µg intra-articular injection (single or multiple doses)

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of localized osteoarthritis of the knee
  • Males willing to use contraception and females who are no longer able to bear children

You may not qualify if:

  • Body Mass Index (BMI) \> 40
  • Grade 0, 3 or 4 osteoarthritis on the Kellgren and Lawrence classification system
  • Injury to the knee or other joint within the last 12 months
  • Receipt of any investigational product or experimental therapeutic procedure within the last 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisArthritisJoint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Study Director
Organization
Calibr, a Division of Scripps Research
KA34ph1@scripps.edu
(858) 242 1000

Study Officials

  • Martin Lotz, MD

    Calibr, a division of Scripps Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 28, 2017

Study Start

May 2, 2018

Primary Completion

April 28, 2020

Study Completion

April 28, 2020

Last Updated

December 27, 2022

Results First Posted

May 17, 2021

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)