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Trial registered on ANZCTR


Registration number
ACTRN12623001233617
Ethics application status
Approved
Date submitted
31/10/2023
Date registered
30/11/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 study to Assess Safety and Tolerability of KER-065 in Healthy Adult Male Volunteers
Scientific title
A Randomized, Phase 1, Double-blind, Placebo-Controlled, 2-Part, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of KER-065 Administered to Healthy Adult Male Volunteers
Secondary ID [1] 310670 0
KER-065-H101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Disease 331579 0
Musculoskeletal Disease 331580 0
Condition category
Condition code
Musculoskeletal 328309 328309 0 0
Other muscular and skeletal disorders
Neurological 328310 328310 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IP Name: KER-065
Treatment Drug - KER-065
Treatment Drug - Placebo

There are 2 parts (Part 1 and Part 2) in this study.
Single Ascending Dose (SAD) Cohorts - Part 1
SAD 1 - Participants will receive 1mg per kg of single dose of subcutaneous KER-065 or placebo on Day 1
SAD 2- Participants will receive 3mg per kg of single dose of subcutaneous KER-065 or placebo on Day 1
SAD 3 - Participants will receive 5mg per kg of single dose of subcutaneous KER-065 or placebo on Day 1

Multiple Ascending Dose (MAD) Cohorts - Part 2
MAD 1 - Participants will receive subcutaneous KER -065 or placebo on Days 1, 29 and 57.
MAD 2 - Participants will receive subcutaneous KER -065 or placebo on Days 1, 29 and 57.
MAD 3- Participants will receive subcutaneous KER-065 or placebo on Days 1, 29 and 57.

Study drug will be administered as a SC injection by trained personnel at the study site.
Initial MAD 1 dose level is based on the review by the safety review committee (SRC) of SAD 1 and SAD2 safety and available PK data.
MAD 2 dose is based on the review by SRC of MAD 1 safety and available PK data and MAD 3 dose is based on the review of MAD 2 safety and available PK data.

In SAD 1-3 the ratio is 4:2, in MAD 1-2 the ratio is 6-2, and in MAD cohort 3 the ratio is 8-2.
Participants are dosed whilst in confinement only and participants in the MAD cohorts will be contacted and reminded of their readmission dates for their second and third doses.
Intervention code [1] 327079 0
Treatment: Drugs
Comparator / control treatment
Placebo is sterile 0.9% normal saline for injection.
Placebo will be used for SAD and MAD cohorts.
Control group
Placebo

Outcomes
Primary outcome [1] 336168 0
To assess the safety and tolerability of escalating doses of KER-065 administered as single and multiple subcutaneous (SC) doses.
Timepoint [1] 336168 0
SAD Cohort
On Day -1 (prior to dosing), and post dose on Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 28 (end of treatment), Day 43 (Safety Follow up), Day 57 (End of study)

MAD Cohort (Dosing on Days 1, 29 and 57)
On Day -1 (prior to dosing) and post dose on Day 1, Day 2, Day 3, Day 5, Day 7,Day11, Day 15, Day 22, Day 28, Day 33, Day 36, Day 43, Day 50, Day 56, Day 57, Day 61, Day 64, Day 71, Day 78, Day 85 (End of treatment), Day 113 (Safety follow up), Day 141 (End of study)

Adverse Events monitored throughout the study.
On dosing days all assessments should be performed before dosing. No windows are provided.
Secondary outcome [1] 427193 0
Evaluate the pharmacokinetic (PK) profile after escalating doses of KER-065 administered as single and multiple SC doses.
Timepoint [1] 427193 0
SAD Cohort
Blood samples collected on Day 1, within 60 minutes before dosing; Day 2, 24 hours post-dose, Day 3, 48 hours post-dose, Day 4, 72 hours post-dose, Day 5, 96 hours post-dose, Day 7, at same nominal time of day as dose administration on Day 1; Days 11, 15, and 22, Days 28, 43, and Day 57.

MAD Cohort (Dosing on Days 1, 29 and 57)
Blood samples collected on Day 1, Day 2, Day 3, Day 5, Day 7,Day11, Day 15, Day 22, Day 29, Day 33, Day 36, Day 43, Day 50, Day 57, Day 61, Day 64, Day 71, Day 78, Day 85 (End of treatment), Day 141 (End of study)
Blood samples will be collected within 60 minutes before dosing on Days 1, 29, and 57

Eligibility
Key inclusion criteria
1. Body mass index (BMI) of greater than or equal to 18.5 to lesser than 30 kg per m2 at the Screening Visit for Part 1 (SAD) only. BMI of greater than or equal to 27 to lesser than or equal to 33 kg per m2 at the Screening Visit for Part 2 (MAD) only.
2. For Part 2 (MAD) only: waist to hip ratio of greater than or equal to 0.9 and body weight of less than 101 kg.
3. Willing to maintain current level of physical activity and will not have major changes in activity (including extremely strenuous or unusual exercise) during Screening and for the duration of the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant illness (as determined by the Investigator or delegate) such as cardiovascular, endocrine, hematologic, hepatic, immunologic, metabolic, gastrointestinal, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases or abnormalities that may affect safety or confound the results of the study.
2. History of bariatric surgery including gastric bypass or gastric sleeve surgery.
3. Malignancy or treatment for malignancy within 3 years before Screening (with the exception of fully excised or treated basal cell carcinoma, or no more than 2 fully treated squamous cell carcinomas of the skin). Participants with a history of malignancy who are
disease-free without treatment for greater than or equal to 3 years are eligible.
4. Serious local infections (e.g., cellulitis, abscess), opportunistic infections (e.g., invasive candidiasis or Pneumocystis pneumonia), or systemic infection (e.g., septicemia) within the 3 months before Screening.
5. Fever (body temperature greater than or equal to37.7°C) or symptomatic viral (including COVID-19, respiratory syncytial virus, influenza) or bacterial infection within 2 weeks before Screening.
6. Major surgery within 3 months before Screening.
7. Donated or lost blood (450 mL or more) or blood products within 30 days before dosing or plans to donate blood or blood products during the study.
8. Systemic corticosteroid therapy for more than 4 weeks within the 6 months before Screening.
9. Positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus.
10.Indwelling permanent pacemakers, metal implants, or similar materials not suitable for DXA or MRI scan. Metal dental fillings are acceptable.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centrally created randomisation list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table centrally created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/12/2023
Actual
13/12/2023
Date of last participant enrolment
Anticipated
17/10/2024
Actual
Date of last data collection
Anticipated
11/03/2025
Actual
Sample size
Target
44
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25587 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 41409 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314891 0
Commercial sector/Industry
Name [1] 314891 0
Keros Therapeutics, Inc.
Country [1] 314891 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Keros Therapeutics, Inc.
Address
1050 Waltham Street, Suite 302, Lexington, MA 02421, USA
Country
United States of America
Secondary sponsor category [1] 316893 0
Commercial sector/Industry
Name [1] 316893 0
Novotech (Australia) Pty Ltd
Address [1] 316893 0
Level 19, 66 Goulburn Street, Sydney NSW 2000, Australia
Country [1] 316893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313886 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313886 0
123 Glen Osmond Road, Eastwood, South Australia 5063, Australia
Ethics committee country [1] 313886 0
Australia
Date submitted for ethics approval [1] 313886 0
27/09/2023
Approval date [1] 313886 0
10/11/2023
Ethics approval number [1] 313886 0

Summary
Brief summary
The primary purpose of the study is to evaluate the safety and tolerability of escalating doses of KER-065 administered as single and multiple subcutaneous doses in healthy adult male volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129674 0
Dr Jonathan Newchurch
Address 129674 0
CMAX, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 129674 0
Australia
Phone 129674 0
+61 423223756
Fax 129674 0
Email 129674 0
jnewchurch@gmail.com
Contact person for public queries
Name 129675 0
Mr Nicholas Tsantes
Address 129675 0
Keros Therapeutics, Inc, 1050 Waltham Street, Suite 302, Lexington, Massachusetts 02421
Country 129675 0
United States of America
Phone 129675 0
+6173146297
Fax 129675 0
Email 129675 0
clinicalstudies@kerostx.com
Contact person for scientific queries
Name 129676 0
Dr Jonathan Newchurch
Address 129676 0
CMAX, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 129676 0
Australia
Phone 129676 0
+61 423223756
Fax 129676 0
Email 129676 0
Jonathan.newchurch@cmax.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No other documents available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.