DS-6016a (Daiichi Sankyo)

DS-6016a (Daiichi Sankyo)

In healthy individuals, the ALK2 receptor protein interacts with Bone Morphogenetic Proteins (BMPs). Through this interaction, normal bone is formed. However, in those with FOP, this mutation leads to a malformed overactive protein resulting in the production of extra bone. The disease progresses throughout the lifetime of the patient sequentially affecting muscle, ligaments, tendons and other connective tissues throughout the body. Mutant ALK2 hyper-responsiveness to BMPs and neo-responsiveness to Activin A provides a rationale for using blocking antibodies to prevent progression of the disease and subsequent ankylosis. DS-60161 is an anti-ALK2 monoclonal antibody developed by Daiichi Sankyo and Saitama Medical University for the treatment of FOP.

About the Clinical Trial

The aim of the DS-6016a

Phase 1
Phase 1: Studies in humans that assess safety and toxicity of a treatment in a small group of healthy volunteers or patients with the disease of interest.  

is to assess the safety, tolerability and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants. The study design will be a single ascending dose study. DS-6016a is highly specific to ALK2 receptor-mediated FOP and has never been tested for any other indication. Daiichi/Sankyo will recruit 48 Japanese healthy male subjects between the ages of 20 and 45 years old with a body mass index between 18.5 and 25.0 kg/M2 at screening. Women or subjects with a history of hypersensitivity or dependence on alcohol or drugs are excluded from participating in the study.

Eligibility Criteria Icon
Eligibility Criteria*
  • AGE: ≤ 20, ≤ 45
  • DISEASE ACTIVITY: None
Study Design Icon
Study Design*
  • STUDY TYPE:  Interventional
  • RANDOMIZED STUDY:  Yes
  • PLACEBO CONTROLLED:  Yes
  • LENGTH OF PARTICIPATION: 9 months
  • NUMBER OF STUDY VISITS: 18
Status Icon
Status

Phase 1, Recruiting

Therapy Approach Icon
Therapy Approach

Anti-ALK-2 monoclonal antibody

Study Sponsor Icon
Study Sponsor

Daiichi Sankyo Co., Ltd.

 

The IFOPA does not endorse nor recommend specific clinical trials. Please speak with your doctor if you are interested in participating in a clinical trial.

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