A single dose study in healthy Japanese participants to evaluate the safety and pharmacokinetics of otilimab.

JRCT ID: jRCT2071210132

Registered date:09/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 23/03/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Single subcutaneous dose of otilimab

Outcome(s)

• Primary Outcome: Serum PK parameters for otilimab:Cmax and AUC(0-inf)

Secondary Outcome

Serum PK parameters for otilimab:AUC(0-t), Tmax, t1/2, Tlast
Occurrence of AEs, serious adverse events(SAEs), and adverse events of special interest(AESIs)
Change from baseline of clinical laboratory values, vital signs, and electrocardiogram(ECG)parameters
Incidence and titers(if applicable)of serum anti-drug antibodies(ADAs)and drug-neutralizing antibodies to otilimab through Week 8

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

-Participant must be 20 to 50 years of age inclusive, at the time of signing the informed consent.
-Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
-A COVID-19 screening with negative test: Two consecutive approved molecular tests (PCR or antigen test)separated by >24 hours. The second test should be within 72 hours of admission to the unit on Day-1.
-Body mass index (BMI)within the range 18.5 to 24.9 kg/m2(inclusive).

Exclude criteria

-History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
-Active infections(including localised infections), or history of recurrent infections(excluding recurrent fungal infections of the nail bed), or has required management of acute or chronic infections.
-History of any respiratory disease which(in the opinion of the investigator)would compromise participant safety or the ability of the participant to complete the study.
-Clinically-significant or unstable(in the opinion of the investigator)persistent cough or dyspnea that is unexplained.
-Current or previous active tuberculosis(TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
-Previous close contact with a person with active TB and did not receive satisfactory anti-tuberculosis treatment as per WHO or national guidelines.
-Haemoglobin <-9 g/dL; white blood cell(WBC)count <-3.0x109/L; platelet count <-100x109/L; absolute neutrophil count(ANC)<-1.0x109/L; lymphocyte count <-0.75x109/L at screening.
-A vaccination(live or attenuated)within 30 days prior to Day 1 or BCG vaccination within 365 days prior to Day 1, or a live vaccination planned during the course of the study. Any COVID-19 vaccination within 14 days prior to enrolment.
-Any surgical procedure, including bone or joint surgery/synovectomy within 8 weeks prior to Day 1 or any planned surgery within the duration of the study.
-Significant allergies to humanised mAb.
-Participants with known COVID-19 positive contacts within 14 days prior to screening.
-History of lymphoma, leukemia, or any malignancy.
-History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
-Use of prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements)within 7 days(or 14 days if the drug is a potential enzyme inducer)or 5 half-lives(whichever is longer)before the start of study intervention until completion of the evaluation visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
NOTE: Acetaminophen, at doses of<-2 grams/day, is permitted.
-Treatment with biologic agents(such as mAb including marketed drugs)within 3 months or 5 half-lives(whichever is longer)prior to dosing.
-Blood donation/sampling within 60 days prior to screening.
-The participant with positive Serological test for syphilis, Human immunodeficiency virus(HIV)antigen/antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1)antibody.
-The participant with positive test for Hepatitis B surface antigen(HBsAg), Hepatitis B core antibody(HBcAb), Hepatitis B surface antibody(HBsAb), or Hepatitis C virus(HCV)antibody.
-Positive pre-study drug/alcohol screen.
-Participants with signs and symptoms suggestive of COVID-19(i.e. fever, cough, etc)within 14 days prior inpatient admission on Day-1.

Related Information

• Primary Sponsor: Yamada Masanori