Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 29 November 2021
• Main ID: NCT03606876
• Date of registration: 12/07/2018
• Prospective Registration: No
• Primary sponsor: Bio-Thera Solutions
• Public title: Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects
• Scientific title: A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects
• Date of first enrolment: June 13, 2018
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03606876
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: yanhua ding
• Affiliation: The First Hospital of Jilin University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed the Inform Consent Form and fully understood the trial conduction, procedure
and potential adverse reactions before entering the trial;

- Willing and able to follow the visits, treatments specified in this study;

- Subjects (including their partners) who are willing to refrain from pregnancy, sperm
donation and take effective contraceptive method in the future 6 months (i.e. 6 months
after study medication), see Appendix 4 for specific contraceptive methods;

- Healthy male subjects at age of 18-55 years (inclusive for both);

- BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg
(inclusive for both);

- Normal physical examinations results or abnormality without clinical significance.

Exclusion Criteria:

- Daily smoking amount of >5 cigarettes within 3 months prior to the trial;

- Any current or history of severe allergic reaction to foods or drugs and History of
allergy to tocilizumab or severe allergic or anaphylactic reactions to human,
humanized, or murine monoclonal antibodies.

- Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or
25 mL spirit, or 125 mL wine);

- Having donated blood or loss of massive blood (> 450 mL) within 3 months prior to
screening, or planning to donate blood or to receive surgery during the study;

- Prior use of prescription medication, over-the-counter drugs, any vitamin products or
herbs within 28 days before screening;

- Having significant changes in diet and exercise habits within 2 weeks before screening
or from screening to dose;

- Having any diseases that increase the risk of bleeding, such as hemorrhoids with
bleeding symptoms, acute gastritis or gastric and duodenal ulcers;

- Color Doppler echocardiography abnormalities with clinical significance;

- Having clinically significant laboratory abnormalities or other clinically indicated
diseases (including but not limited to gastrointestinal, renal, liver, neurological,
hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases);

- Ineligible subjects based on investigator's judgement.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: BAT1806 injection

Primary Outcome(s)

Pharmacokinetics Endpoint [Time Frame: 0-2months]

Secondary Outcome(s)

Pharmacokinetics Endpoint [Time Frame: 0-2months]

Secondary ID(s)

BAT-1806-001-CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors