A Study to Evaluate the Safety and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for fibrosis and oncology. This study is a four-part trial consisting of Parts A, B C and D. Parts A and B are presented in this record, while Parts C and D are currently not recruiting.

The primary objective in Parts A and B of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of single and multiple doses of LASN01 in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lassen Therapeutics 1, Inc.

Criteria

Inclusion Criteria:

Part A and Part B only:

• Males or females, 18 through 60 years of age, inclusive.

• Body weight ≥110 pounds (≥50 kg); body mass index within the range of 18 through 30.0 kg/m2.

• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, physical examination, and laboratory evaluations.

Exclusion Criteria:

Parts A and B

• Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to participate in and complete this clinical study.

• Currently receiving any antibiotics for upper or lower respiratory tract infections

• Use of any prescription drug within 21 days of check-in or any over-the-counter preparation, herbal supplement, vitamin or mineral within 7 days of check-in must be approved

• Any prescription biologic within 3 months or 5 half-lives of check-in

• Any inhaled or nasal corticosteroids in the 4 weeks before check-in or any oral corticosteroids in the 8 weeks before check-in

• Participation in any other investigational study drug trial in which an investigational study drug was administered within 30 days or an investigational biological study drug was administered within 3 months before check-in.