A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10
Study Details
- Unmapped
- Drug: SCTB10
- Drug: Placebo
- Provision of written informed consent prior to initiation of any study procedures.
- Healthy male participants aged 18 to 50 years (inclusive).
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
- Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.
- History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
- History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
- Presence of high-risk factors for thrombosis.
- Clinically significant abnormal findings during screening, as determined by the investigator.
- Abnormal infectious disease screening results.
- Abnormal results in urine drug screening or breath alcohol test.
- Use of any medication or dietary supplements within 14 days prior to the first dose.
- Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
- Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.