A phase 1, randomized, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic profiles of OLX10010 in healthy subjects compared to placebo
- Conditions
- Healthy subjects without significant conditionsNot Applicable
- Registration Number
- ISRCTN64317949
- Lead Sponsor
- OliX Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia [e.g., Gilbert’s syndrome] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee)
4. Female subjects will be non-pregnant and non-lactating
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions
1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (i.e., a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check-in until 90 days after the Follow-up Visit
2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e., a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow-up Visit. a. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
4. Subjects with serum creatinine >ULN
5. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
6. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
7. Alcohol consumption of >28 units per week for males and >21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits
8. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check-in
9. Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator
10. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half-lives, whichever is longer) prior to Check-in
11. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks, or chocolates (>8 cups of coffee or equivalent per day)
12. Consumption of food or drinks containing poppy seeds, grapefruit, or Seville oranges from 7 days prior to Screening
13. Use, or intend to use, any prescription medications/products other than oral, implantable, transdermal, injectable, or intrauterine contraceptives, or hormone replacement therapy, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
14. Use, or intend to use, slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
15. Use, or intend to use, any non-prescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
16. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in
17. Receipt of blood products within 2 months prior to Check-in
18. Donation of blood
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of single subcutaneous and intradermal doses, and multiple intradermal doses of OLX10010. Safety and tolerability are evaluated by adverse events upon checking clinical symptoms, lab values, injection site tolerability, and so on. Single dose ascending groups will be monitored at Day 14. Multiple dose ascending groups will be treated with OLX10010 or placebo 3 times on Day 1, 15, and 29, and their safety profiles are monitored up to Day 43.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of OLX10010 will be evaluated. The blood samples are collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.