A single-center, open-label, Phase I study to investigate the pharmacokinetics, safety, and tolerability of gantenerumab in healthy Chinese participants following single subcutaneous administration of a high-concentration liquid formulation in the abdomen

Genentech, Inc.0 sites20 target enrollmentJune 25, 2021

ConditionsPharmacokinetics, safety, and tolerability of gantenerumab Not Applicable

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pharmacokinetics, safety, and tolerability of gantenerumab
Sponsor: Genentech, Inc.
Enrollment: 20
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 25, 2021

End Date

October 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Healthy Chinese male and female subjects who are 18 to 60 years of age, inclusive, at the time of signing informed consent form (ICF)
•2\. Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12\-lead electrocardiogram (ECG), hematology, blood chemistry, coagulation, serology, and urinalysis. Some medical conditions are allowed that are well controlled by stable medication.
•3\. A body mass index (BMI) between 18\.0 and 30\.0 kg/m², inclusive
•4\. A body weight between 50 to 100 kg, inclusive
•5\. For women of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as defined below:
•5\.1\. Women must remain abstinent or use contraceptive methods that result in a failure rate of \<1% per year for at least 17 weeks after dosing.
•5\.2\. A woman is considered to be of reproductive potential if she is postmenarcheal, has not reached a postmenopausal state (\=12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of reproductive potential may be adapted for alignment with local guidelines or requirements.
•5\.3\. Examples of contraceptive methods that result in a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone\-releasing intrauterine devices, and copper intrauterine devices.
•The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
•9\. Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

•1\. History of any clinically significant gastrointestinal, renal, hepatic, broncho\-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
•2\. History or suspicion of drug abuse and/or drug addiction
•3\. History or suspicion of alcohol abuse and/or alcohol addiction. Consumption of alcohol will not be allowed from 48 hours before dosing until the end of the residential period (Day 3\) and should be limited to a maximum of 14 drinks per week for males and 7 drinks per week for females (1 drink \= 12 g of pure alcohol) during the out\-clinic period until follow\-up.
•4\. Smokers who smoke more than 10 cigarettes per day or an equivalent amount of tobacco as determined by history. Healthy volunteers must be able to abstain from smoking from 48 hours before dosing until the end of the residential period (Day 3\).
•5\. Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
•6\. Positive serum pregnancy test result at screening or Day \-1 for women of childbearing potential
•7\. Known human immunodeficiency virus (HIV) infection or positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV\-1 antibody
•8\. Any familial history of early onset of AD
•9\. Participants who are \>49 years of age with a MoCA score lower than 26
•10\. Confirmed (may use an average of \=3 blood pressure measurements), supine systolic blood pressure (SBP) \<90 mmHg or \>140 mmHg or diastolic blood pressure (DBP) \<50 mmHg or \>90 mmHg at screening or Day \-1