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Trial registered on ANZCTR
Registration number
ACTRN12621001077853
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
16/08/2021
Date last updated
30/05/2024
Date data sharing statement initially provided
16/08/2021
Date results information initially provided
4/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of KER-012 Administered to Healthy, Postmenopausal Women
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Scientific title
A Randomized, Double-Blind, Placebo Controlled, Two-Part, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of KER-012 Administered to Healthy, Postmenopausal Women
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Secondary ID [1]
304510
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KER012-HV-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Postmenopausal Women
322395
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Condition category
Condition code
Musculoskeletal
320054
320054
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0
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Osteoporosis
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Cardiovascular
320197
320197
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0
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Hypertension
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Musculoskeletal
320198
320198
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
KER-012 will be administered subcutaneously. Intervention adherence will be assessed by study monitors, this will be done by audit of nurses notes and pharmacy logs
The study consists of two parts:
Single Ascending Dose: 4 cohorts of 10 participants randomized 4 (study drug): 1 (placebo)
Cohort 1: 0.75 mg/kg single subcutaneous on day 1
Cohort 2: 1.5 mg/kg on single subcutaneous on day 1
Cohort 3: 3 mg/kg on single subcutaneous on day 1
Cohort 4: 5 mg/kg on single subcutaneous on day 1
Multiple Ascending Dose: 3 cohorts of 8 participants randomized 3 (study drug): 1 (placebo)
Cohort 1: 0.75 mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57
Cohort 2: 1.5 mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57
Cohort 3: 4.5 mg/kg subcutaneous on every 4 weeks (Q4W) on Days 1, 29, and 57 or dosing every 2 weeks (Q2W) on Days 1, 15, 29, 43, and 57
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Intervention code [1]
320868
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Treatment: Drugs
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Comparator / control treatment
The placebo will be sterile saline and will be administered subcutaneously
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Part 1/ Part 2: To evaluate the safety and tolerability of escalating doses of KER-012 administered as single and multiple SC doses in healthy postmenopausal women.
To be assessed by monitoring
• Incidence and severity of adverse events (AE);
• Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;
• Clinically significant changes from baseline in:
- Laboratory evaluations (hematology, chemistry, urinalysis, function tests);
- Electrocardiograms (ECG);
- Vital signs;
- Physical examinations;
- Anti-drug antibodies
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Assessment method [1]
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Timepoint [1]
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Part 1/ Part 2: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57
Part 2 (every four weeks; Q4W): From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 28, Day 29, Day 33, Day 36, Day 43, Day 50, Day 56, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113
Part 2 (every two weeks; Q2W): From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 14, Day 15, Day 22, Day 28, Day 29, Day 33, Day 36, Day 42, Day 43, Day 50, Day 56, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113
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Secondary outcome [1]
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Part 1/ Part 2: To evaluate the pharmacokinetic profile following escalating doses of KER-012 administered as single and multiple SC doses
The following parameters will be used for pharmacokinetic assessment: Maximum concentration (Cmax), Time to maximum concentration (tmax), Area under the concentration-time curve from time 0 to last (AUC0-last), Area under the concentration-time curve from time 0 to infinity (AUC0-inf), Terminal elimination half-life (t1/2), Apparent clearance (CL/F), Apparent volume of distribution (Vz/F), Minimum concentration (Ctrough), Area under the concentration-time curve over the dosing interval AUC (0-tau), Accumulation ratio (Rac).
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Assessment method [1]
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Timepoint [1]
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Part 1: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration
Part 2 (every four weeks; Q4W): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration
Part 2 (every two weeks; Q2W): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration
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Secondary outcome [2]
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Part 1/ Part 2: To assess the pharmacodynamic effect on follicle-stimulating hormone (FSH) following escalating doses of KER-012 administered as single and multiple SC doses as assessed in change from baseline
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Assessment method [2]
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Timepoint [2]
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Part 1: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration
Part 2 (every four weeks or every two weeks): From baseline to Day 1, Day 2, Day 3, Day 5, Day 7, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 58, Day 59, Day 61, Day 63, Day 67, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration
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Secondary outcome [3]
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Part 1/ Part 2: To assess the pharmacodynamic effect on bone tissue following escalating doses of KER-012 administered as single and multiple SC doses
In Part 1 and Part 2 of this study, the pharmacodynamic effect will be assessed based on change from baseline in biomarkers of bone growth and resorption
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Assessment method [3]
396983
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Timepoint [3]
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Part 1: Day 1, Day 5, Day 7, Day 15, Day 22, Day 29, Day 43, Day 57 post intervention administration
Part 2 (every four weeks; Q4W): Day 1, Day 7, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 63, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration
Part 2 (every two weeks; Q2W): Day 1, Day 7, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 63, Day 71, Day 78, Day 85, Day 99, Day 113 post intervention administration
The dual-energy X-ray absorptiometry (DXA) assessment is to be conducted within 7 days of dosing (not as part of the initial Screening visit)
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Secondary outcome [4]
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Part 2: To assess the pharmacodynamic effect on bone tissue following escalating doses of KER-012 administered as single and multiple SC doses
The pharmacodynamic effect will be assessed based on change from baseline in lean body mass, fat mass, and bone mineral density (BMD) using total body scan by dual-energy X-ray absorptiometry (DXA).
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Assessment method [4]
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Timepoint [4]
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Part 2 (every four weeks; Q4W or every two weeks; Q2W): From baseline to Day 56, Day 113 post intervention administration
The dual-energy X-ray absorptiometry (DXA) assessment is to be conducted within 7 days of dosing (not as part of the initial Screening visit)
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Eligibility
Key inclusion criteria
For part 1 and part 2:
1. Postmenopausal female, aged 45 to 70 years (inclusive) at Screening.
more than or equal to 6 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
2. Non-smoker or social smoker who agrees to smoke less than or equal to 8 cigarettes per week or is willing to abstain from smoking/nicotine products during the study including the follow-up period.
3. Body mass index of >18.5 kg/m2 to <32 kg/m2 at Screening.
4. In good health as determined by review of medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, 12-lead electrocardiogram (ECG), and any abnormal findings that are assessed as not clinically significant by the Investigator.
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Minimum age
45
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
For part 1 and part 2:
1. Clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
2. History of or current malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years, or cervical intraepithelial neoplasia >5 years ago that was treated and not known to have recurred).
3. Current opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
4. Serious local infections (e.g., cellulitis, abscess) or systemic infection (eg, septicemia) within the 3 months prior to Screening.
5. History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational drug
6. Surgery within 3 months prior to Screening (exception is various minor procedures [e.g., mole removal, minor cosmetic procedures, or minor dental procedures]).
7. Clinically relevant/significant laboratory findings at Screening (up to 1 repeat permitted) or on Day -1 (repeats not permitted) including, but not limited to: Alanine transaminase (ALT) and aspartate transaminase (AST) >1.2 × upper limit of normal (ULN); isolated and mainly unconjugated hyperbilirubinemia consistent with Gilbert's should not be excluded.
8. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening that has not resolved prior to dosing.
9. Donated blood (1 unit or more) within 1 month prior to dosing or plans to donate blood during the study.
10. Hormone replacement therapy (i.e., estrogen, or estrogen plus progesterone) within 3 months prior to dosing or plans to begin hormone replacement therapy at any time during the study. Local estrogen therapy for vaginal atrophy replacement is permitted.
11. Systemic glucocorticoid therapy for more than 1 month within 6 months before Screening.
12. Changes in medications that may affect muscle function (e.g., high intensity statins, beta-blockers) within 3 months prior to dosing. Dose to remain stable while on study.
13. History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to Screening.
14. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 5 half-lives prior to dosing.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. The allocation will occur via numbered containers at the investigational product manufacturing facility as such they will be the holder of the allocation schedule
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization schedule will be prepared by an unblinded statistician prior to the start of the study. Investigational product will be prepared in accordance with the randomization list
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
Single-ascending dose (SAD) cohorts: participants in each cohort will be randomized in a ratio of 4:1 to KER-012 or placebo
Participants will be screened within 28 days prior to dosing and will report to the study site over a 12 week period
Multiple-ascending dose (MAD) cohorts: participants will be randomized in a ratio of 4:1 to KER-012 or placebo in cohort 1, 3:1 to KER-012 or placebo in cohort 2 and 3
Participants will be screened within 28 days prior to dosing and will report to the study site over a 20 week period
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
Part 1 (single-ascending dose) and Part 2 (multiple-ascending dose) data will be analysed separately. In general, data will be summarized by dose group, with participants receiving placebo pooled across cohorts. Data will be summarized using descriptive statistics (mean, median, standard deviation, minimum, and maximum) or frequency counts and percentages, as appropriate to the type of data. Baseline will be defined as the last available, valid, non-missing assessment prior to dosing.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/08/2021
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Actual
30/08/2021
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Date of last participant enrolment
Anticipated
13/02/2022
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Actual
10/03/2022
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Date of last data collection
Anticipated
30/06/2022
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Actual
30/06/2022
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Sample size
Target
80
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
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Recruitment hospital [2]
19847
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
34536
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4007 - Herston
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Recruitment postcode(s) [2]
34537
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
308875
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Commercial sector/Industry
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Name [1]
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Keros Therapeutics, Inc.
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Address [1]
308875
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99 Hayden Avenue, Suite 120, Building E, Lexington, MA 02421, USA
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Country [1]
308875
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Keros Therapeutics, Inc.
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Address
99 Hayden Avenue, Suite 120, Building E, Lexington, MA 02421, USA
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Country
United States of America
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Secondary sponsor category [1]
309794
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None
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Name [1]
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Address [1]
309794
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Country [1]
309794
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Other collaborator category [1]
281864
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Commercial sector/Industry
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Name [1]
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Novotech (Australia) Pty Limited
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Address [1]
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Level 3, 235 Pyrmont street, Pyrmont NSW 2009
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Country [1]
281864
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital HREC
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Ethics committee address [1]
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55 Commercial Road, Melbourne VIC 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/06/2021
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Approval date [1]
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27/07/2021
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Ethics approval number [1]
308780
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Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD, Part 1) and multiple-ascending dose study (MAD, Part 2) of KER-012 in healthy postmenopausal women. The study will evaluate the safety, tolerability and PK of KER-012. In addition, this study will explore the effects of KER-012 on muscle, bone, and adipose tissues, and determine the pharmacokinetic/pharmacodynamic (PD) relationship of those effects.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Richard Friend
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Address
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Nucleus Network – Brisbane, 300c Herston Road, Herston, Queensland, 4006
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Country
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Australia
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Phone
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+61 403 415 925
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Richard Friend
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Address
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Nucleus Network – Brisbane, 300c Herston Road, Herston, Queensland, 4006
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Country
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Australia
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Phone
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+61 403 415 925
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Manny Marquez
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Address
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Novotech (Australia) Pty Limited, Level 3, 235 Pyrmont street, Pyrmont NSW 2009
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Country
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Australia
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Phone
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+61 291713249
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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