Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Latigo Biotherapeutics
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent.
Must agree to use an adequate method of contraception (as defined in Section 9.4.
Healthy males or non-pregnant, non-lactating, healthy females.
Body mass index of 18.0 to 32.0 kg/m2 as measured at screening.
Weight ≥50 kg at screening.
You may not be if
Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, as judged by the investigator.
Have poor venous access that limits phlebotomy.
Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Participants with Gilbert's Syndrome are allowed.
Has ALT or AST \>1.5 × ULN; Total bilirubin \>1.5 × ULN (for participants with known Gilbert's syndrome these criteria only apply if the total bilirubin \>1.5 × ULN as long as direct bilirubin is ≤1.5 × ULN) at screening.
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<90 mL/min using the Cockcroft-Gault equation
Positive HBsAg, HCV Ab or HIV antibody results at screening.
Positive serum pregnancy test at screening or positive urine pregnancy test at first
Participants who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days.
Participants who report to have previously received LTG-001. admission. Those who are pregnant or lactating will be excluded.
Personal or family history of long QT syndrome or a QTcF interval \> 450 msec for men or \> 470 for women on screening or first admission ECG. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or oral contraception) in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
Participants who have had any vaccine within 15 days before first IMP administration History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
A confirmed positive alcohol urine test at screening or first admission.
Current smokers and those who have smoked within the last 12 months.
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
A confirmed positive urine cotinine test at screening or first admission.
Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1) Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication.
Participants who are, or are immediate family members of, a study site or sponsor employee.
Failure to satisfy the investigator of fitness to participate for any other reason.
