CompletedPhase 1ACTRN12623001233617

A Phase 1 study to Assess Safety and Tolerability of KER-065 in Healthy Adult Volunteers

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 Volunteers

Sponsor

Keros Therapeutics, Inc.

Enrollment

38 participants

Start Date

Dec 15, 2023

Study Type

Interventional

Conditions

Musculoskeletal Disease

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 volunteers.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

Body mass index (BMI) of greater than or equal to 18.5 through less than or equal to 35 kg per m2 at the Screening Visit for Part 1 (SAD) only. BMI of greater than or equal to 27 to less than or equal to 35 kg per m2 at the Screening Visit for Part 2 (MAD) only.
For Part 2 (MAD) only: waist to hip ratio of greater than or equal to 0.8 and body weight of less than or equal to 120 kg at screening visit.
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.

Exclusion Criteria11

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.
History of bariatric surgery including gastric bypass or gastric sleeve surgery.
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.
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.
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 dosing.
Major surgery within 3 months before Screening.
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.
Systemic corticosteroid therapy for more than 4 weeks within the 6 months before Screening.
Positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus.
Indwelling permanent pacemakers, metal implants, or similar materials not suitable for DXA or MRI scan. Metal dental fillings are acceptable.

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Interventions

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

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 2mg per kg 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. Study drug will be administered as a SC injection by trained personnel at the study site. Initial MAD 1 dose level is 2mg/kg 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. In SAD 1-3 the ratio is 4:2, in MAD 1 the ratio is 6:2 and MAD 2 the ratio is 8:4. Participants are dosed whilst in confinement only and participants in MAD cohorts will be contacted and reminded of their readmission dates for their second and third doses.