Status:
COMPLETED
Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994
Lead Sponsor:
Spero Therapeutics
Collaborating Sponsors:
CPR Pharma Services Pty Ltd, Australia
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study will be conducted in 2 parts: a single ascending dose (SAD) part, followed by a multiple ascending dose (MAD) ...
Detailed Description
This study is a randomized, double-blind, placebo-controlled, combined single and multiple ascending dose (SAD and MAD) trial. Up to one hundred fifty two (152) subjects aged 18-55, who fulfill the in...
Eligibility Criteria
Inclusion
- Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening;
- Body mass index ≥ 18.5 and ≤ 29.9 (kg/m2) and 55.0 and 100.0 kg (inclusive) for all cohorts;
- Medically healthy without clinically significant (CS) abnormalities at the screening visit or Day -1, including:
- Physical examination, vital signs including temperature, heart rate, respiratory rate, and blood pressure;
- Triplicate electrocardiograms (ECGs) taken at least 1 minute apart with QT wave corrected for heart rate (HR) using Fridericia's method (QTcF) interval duration less than 450 msec obtained as an average from the triplicate screening and pre-dose Day 1 ECGs after at least 5 min in a semi-supine quiet rest;
- Haemoglobin \> 12.5, haematocrit 37%, white blood cell (WBC) count \> 3.5, or platelet count equal to or greater than the lower limit of normal range of the reference laboratory (may be confirmed upon repeat analysis);
- Creatinine, blood urea nitrogen (BUN), equal to or less than the upper limit of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to or \< 1.5 times the upper limit of normal for the reference laboratory and confirmed on repeat analysis; results of all other clinical chemistry and urine analytes without any CS abnormality.
- Discussion between the PI and the Sponsor Medical Monitor is encouraged regarding any abnormal laboratory value that is outside of the normal range during the pre-dose period.
- Be non-smokers (including tobacco, e-cigarettes or marijuana) for at least 1 month prior to participation in the study;
- Willing and able to provide written informed consent;
- Be willing and able to comply with all study assessments and adhere to the protocol schedule;
- Have suitable venous access for blood sampling;
- If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by follicle stimulating hormone or surgical sterilization i.e., tubal ligation or hysterectomy). Provision of documentation is not required for female sterilization, verbal confirmation is adequate;
- If male, a willingness not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation). This criterion applies to males (and/or female partners) who are surgically sterile and must be followed from the time of first study drug administration until 30 days after the final administration of study drug.
Exclusion
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
- History of known or suspected Clostridium difficile infection;
- History of seizure disorders, except for a single febrile seizure in childhood;
- Positive urine drug/alcohol testing at screening or Day -1;
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV);
- History of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where 1 standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 ml nip spirits, or 100 ml wine) within the previous 5 years;
- Use of any prescription medication or any over-the-counter medication, including herbal products and vitamins within 7 days prior to randomization;
- Documented hypersensitivity reaction or anaphylaxis to any medication;
- Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrollment;
- Participation in another investigational clinical trial within 30 days prior to Day 1;
- Any other condition or prior therapy, which, in the opinion of the PI, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2018
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03395249
Start Date
October 20 2017
End Date
August 2 2018
Last Update
August 28 2018
Active Locations (1)
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1
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031