Osteoarthritis, KneePhase 1NCT03133676

A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis

A Phase 1 study testing KA34 in people with Osteoarthritis, Knee, run by Calibr, a division of Scripps Research at 4 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: KA34
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 4 sitesUnited States
Study dates: 2 May 2018to 28 Apr 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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Research of West Florida
Clearwater, Florida, 33765
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Bioclinica Research
Orlando, Florida, 32806
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 Administered Via Intra-Articular Injection in Subjects With Osteoarthritis of the Knee

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

Read the detailed description

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee. OA patients are randomized to receive either placebo or KA34 active drug in the range of 50-400 ug by intra-articular injection. The first portion of the study is with single ascending doses, the second portion of the study is with multiple ascending doses.

Conditions: Osteoarthritis, Knee
Being tested: KA34, Placebo
Keywords: Osteoarthritis, Arthritis, Joint Disease, Osteoarthritis, Knee
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis, Arthritis, Joint Diseases

What participants receive

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

KA34Drug
Also called KA-34
50 µg - 400 µg intra-articular injection (single or multiple doses)
PlaceboDrug
50 µg - 400 µg intra-articular injection (single or multiple doses)

Study groups in NCT03133676
Study group	Role	What they receive
KA34 Active Drug	Experimental	KA34 active drug in the dose range of 50 - 400 ug per knee Receives: Drug: KA34
Placebo	Placebo comparator	Placebo is the formulation for KA34. Receives: Drug: Placebo

What is being measured

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

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.
Measured: 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.
Measured: Day 1 up to Day 180

Secondary outcomes (28)

SAD Part: Mean Change From Baseline in Hemoglobin at Day 8
The mean changes from baseline at Day 8 in hemoglobin levels for subjects in the SAD part of the study are presented.
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in Hemoglobin at Day 180
The mean changes from baseline at Day 180 in hemoglobin levels for subjects in the MAD part of the study are presented.
Measured: Baseline and Day 180
SAD Part: Mean Change From Baseline in Hematocrit at Day 8
The mean changes from baseline at Day 8 in hematocrit levels for subjects in the SAD part of the study are presented.
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in Hematocrit at Day 180
The mean changes from baseline at Day 180 in hematocrit levels for subjects in the MAD part of the study are presented.
Measured: Baseline and Day 180
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
The mean changes from baseline at Day 8 in total bilirubin and creatinine for subjects in the SAD part of the study are presented.
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
The mean changes from baseline at Day 180 in total bilirubin and creatinine for subjects in the MAD part of the study are presented.
Measured: Baseline and Day 180
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
The mean changes from baseline at Day 8 in the following liver enzyme levels are presented for subjects in the SAD part of the study: alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
The mean changes from baseline at Day 180 in the following liver enzyme levels are presented for subjects in the MAD part of the study: ALP, ALT and AST.
Measured: Baseline and Day 180
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
The mean changes from baseline at Day 8 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for subjects in the SAD part of the study are presented.
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
The mean changes from baseline at Day 180 in SBP and DBP for subjects in the MAD part of the study are presented.
Measured: Baseline and Day 180
SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8
The mean changes from baseline at Day 8 in the electrocardiogram (ECG) parameter QTcF interval for subjects in the SAD part of the study are presented.
Measured: Baseline and Day 8
MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180
The mean changes from baseline at Day 180 in the ECG parameter QTcF interval for subjects in the MAD part of the study are presented.
Measured: Baseline and Day 180
SAD Part: Number of Subjects With Injection Site TEAEs
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Measured: Baseline up to Day 29
MAD Part: Number of Subjects With Injection Site TEAEs
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Measured: Baseline up to Day 180
SAD Part: Mean Maximum Plasma Concentration (Cmax)
All Pharmacokinetic (PK) samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean Cmax
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the MAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Median Tmax
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the MAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t])
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean AUC(0-t)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the MAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean AUC(0-inf)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values are presented for subjects who received KA34 in the MAD part of the study.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Terminal Half-life (t1/2)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean t1/2
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the MAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Clearance (CL/F)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the SAD part of the study.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean CL/F
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the MAD part of the study.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Volume of Distribution (Vz/F)
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the SAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean Vz/F
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the MAD part of the study are presented.
Measured: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29

Timeline

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

2 May 201828 Apr 2020

First posted28 Apr 2017
Study start2 May 2018
Primary completion28 Apr 2020
Study completion28 Apr 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 Osteoarthritis, KneeStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03133676
Sponsor's protocol ID: CBR-KA34-3001
Status last verified: Dec 2022
First submitted: 20 Apr 2017
Last updated: 27 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
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

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 Administered Via Intra-Articular Injection in Subjects With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT03133676
Acronym / sponsor ID: CBR-KA34-3001
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Arthritis, Joint Disease, Osteoarthritis, Knee
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Calibr, a division of Scripps ResearchUniversity, hospital or other
Collaborators: California Institute for Regenerative Medicine (CIRM)
Study start: 2 May 2018 (actual)
Primary completion: 28 Apr 2020 (actual)
Study completion: 28 Apr 2020 (actual)
First posted: 28 Apr 2017 (actual)
Results: Posted 17 May 2021

Clinical summary

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

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
KA34 Active Drug	Experimental	Drug: KA34KA34 active drug in the dose range of 50 - 400 ug per knee
Placebo	Placebo comparator	Drug: PlaceboPlacebo is the formulation for KA34.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

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
KA34Also: KA-3450 µg - 400 µg intra-articular injection (single or multiple doses)	Drug	KA34 Active Drug
Placebo50 µg - 400 µg intra-articular injection (single or multiple doses)	Drug	Placebo

Primary outcome

SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 29
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.
MAD Part: Number of Subjects Who Experienced TEAEs
Time frame: Day 1 up to Day 180
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.

28 secondary outcomes

SAD Part: Mean Change From Baseline in Hemoglobin at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in Hemoglobin at Day 180
Time frame: Baseline and Day 180
SAD Part: Mean Change From Baseline in Hematocrit at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in Hematocrit at Day 180
Time frame: Baseline and Day 180
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
Time frame: Baseline and Day 180
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
Time frame: Baseline and Day 180
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
Time frame: Baseline and Day 180
SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8
Time frame: Baseline and Day 8
MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180
Time frame: Baseline and Day 180
SAD Part: Number of Subjects With Injection Site TEAEs
Time frame: Baseline up to Day 29
MAD Part: Number of Subjects With Injection Site TEAEs
Time frame: Baseline up to Day 180
SAD Part: Mean Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean Cmax
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Median Tmax
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t])
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean AUC(0-t)
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean AUC(0-inf)
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Terminal Half-life (t1/2)
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean t1/2
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Clearance (CL/F)
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean CL/F
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
SAD Part: Mean Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose up to 4 hours post-dose on Day 1
MAD Part: Mean Vz/F
Time frame: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29

Results and safety

Results posted to the registry on 17 May 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
Placebo (SAD)	6	6
Cohort 1: KA34 50 µg (SAD)	3	3
Cohort 2: KA34 100 µg (SAD)	3	3
Cohort 3: KA34 200 µg (SAD)	6	6
Cohort 4: KA34 400 µg (SAD)	6	6
Placebo (MAD)	9	9
Cohort 5: KA34 100 µg (MAD)	9	9
Cohort 6: KA34 200 µg (MAD)	9	9
Cohort 7: KA34 400 µg (MAD)	9	9

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

Time frame: Day 1 up to Day 29. Count of participants. Unit: Participants

Measure	Placebo (SAD) n = 6	Cohort 1: KA34 50 µg (SAD) n = 3	Cohort 2: KA34 100 µg (SAD) n = 3	Cohort 3: KA34 200 µg (SAD) n = 6	Cohort 4: KA34 400 µg (SAD) n = 6
At least 1 TEAE	1	2	1	4	1
At least 1 related TEAE	0	0	0	2	0
At least 1 severe TEAE	0	0	0	0	0
At least 1 severe related TEAE	0	0	0	0	0
At least 1 SAE	0	0	0	1	0
TEAE leading to discontinuation	0	0	0	0	0
TEAE leading to death	0	0	0	0	0
TEAE with CTCAE grade >=3	0	0	0	0	0

Population analysed: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.

Primary outcome: MAD Part: Number of Subjects Who Experienced TEAEs

Time frame: Day 1 up to Day 180. Count of participants. Unit: Participants

Measure	Placebo (MAD) n = 9	Cohort 5: KA34 100 µg (MAD) n = 9	Cohort 6: KA34 200 µg (MAD) n = 9	Cohort 7: KA34 400 µg (MAD) n = 9
At least 1 TEAE	7	3	6	5
At least 1 related TEAE	4	1	1	0
At least 1 severe TEAE	1	0	0	0
At least 1 severe related TEAE	0	0	0	0
At least 1 SAE	0	0	0	0
TEAE leading to discontinuation	0	0	0	0
TEAE leading to death	0	0	0	0
TEAE with CTCAE grade >=3	1	0	0	0

Population analysed: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (SAD)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cohort 1: KA34 50 µg (SAD)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Cohort 2: KA34 100 µg (SAD)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 3: KA34 200 µg (SAD)	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
Cohort 4: KA34 400 µg (SAD)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Placebo (MAD)	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
Cohort 5: KA34 100 µg (MAD)	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 6: KA34 200 µg (MAD)	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Cohort 7: KA34 400 µg (MAD)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Martin Lotz, MD study director

Calibr, a division of Scripps Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KA34 in people with Osteoarthritis, Knee, run by Calibr, a division of Scripps Research at 4 sites in United States.

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 2 inclusion and 4 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 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 17 May 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?

SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) (time frame: Day 1 up to Day 29). The study lists 2 primary outcomes in all. 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 NCT03133676.

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 27 Dec 2022.