A study comparing extended release and immediate release formulations of EQ121 following single doses in healthy adult volunteers- Part A
- Conditions
- Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12622000307707
- Lead Sponsor
- EQRx International, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
1. Are capable of giving informed consent and complying with study procedures;
2. Healthy male or female participants, between the ages of 18 and 65 years, inclusive;
3. BMI of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
4. Female participants must not be currently breast-feeding, and must meet one of the following criteria:
a. Surgically sterile for at least 3 months prior to Screening by one of the following means:
• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)
b. Postmenopausal, defined as the following:
• Last menstrual period greater than 12 months prior to Screening without an alternative medical cause, AND
• Postmenopausal status confirmed by serum FSH concentration at Screening greater than 40 mIU/mL
c. Women of childbearing potential (WOCBP):
• Must not have a positive serum pregnancy test at Screening and must have a negative urine pregnancy test on admission
• Must use at least one of the following protocol-specified highly effective methods of birth control, AND must agree to use barrier contraception (male condom) during heterosexual intercourse, from the time of Screening until at least 30 days after the last dose of study drug:
• Partner vasectomy (at least 6 months prior to Screening; vasectomized partner should be the sole partner of the female participant)
• Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal, injectable)
• Progestogen-only hormonal contraception (oral, injectable, implantable)
• Implantable device (implantable rod or intrauterine device)
Alternatively, WOCBP must practice complete abstinence (defined as refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant; periodic abstinence and withdrawal are not acceptable) from Screening until at least 30 days after the last dose of study drug. It is not necessary to use any other method of contraception when complete abstinence is elected. WOCBP who choose complete abstinence must continue to have pregnancy tests as per protocol. The reliability of sexual abstinence needs to be evaluated by the PI or designee in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
5. Male participants must agree to utilize a highly effective method of contraception (condom) during heterosexual intercourse from clinic admission until 90 days following the last dose of study drug and must refrain from donating sperm for this same period. Vasectomized males do not need to use additional forms of contraception providing that the procedure was performed at least 12 weeks prior to Screening and an absence of sperm in the ejaculate has been documented. Total sexual abstinence may be considered acceptable at the discretion of the PI or designee;
6. Considered healthy by the PI or designee, based on participant’s reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
1. Inability to attend all the study visits or comply with study procedures;
2. Evidence or clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the PI or designee;
3. Hospital admission or major surgery within 3 months prior to Screening;
4. A history of drug abuse, or a positive test at Screening or Admission for drugs of abuse;
5. A history of alcohol abuse according to medical history within 6 months prior to Screening (drinking 14 units of alcohol per week: 1 unit equal to 360 mL of beer, or 37 mL of spirits, or 120 mL of wine) at Screening or upon admission to the clinical site;
6. Positive screen for drugs of abuse or alcohol at Screening or at Admission;
7. A history of organ transplant, including history of bone marrow transplant;
8. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer), or any injectable prescription medications within 30 days or 10 half-lives (whichever is longer), of the first dose of study drug
9. Taken an investigational drug within 3 months or 5 half-live, whichever is longer, from the Screening date
10. Any liver LFT value greater than 1.5 of ULN which includes aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase, and gamma-glutamyl transferase (GGT) at Screening or at Admission
11. Any white blood cell (WBC), absolute neutrophil count (ANC), hemoglobin, or platelet count less than the lower limit of normal at Screening or at Admission that is clinically significant in the opinion of the PI or designee
12. Serum creatinine more than upper limit of normal (ULN) at Screening or Admission
13. Any condition or finding that in the opinion of the PI or designee would put the participant or study conduct at risk if the participant were to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method