A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101

Launched by ALECTOR INC. · Sep 30, 2019

Keywords

ClinConnect Summary

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BMI 18.0-35.0 kg/m2
• • 45-120 kg, inclusive
• • At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
• • Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
• • In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
• • Willingness and able to comply with the study protocol, in the investigator's judgement.
• Exclusion Criteria:
• • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
• • Positive drug or alcohol at screening and prior to first dose
• • History of alcohol abuse or substance abuse